Forceps Suppliers
Limit companies to: Worldwide USA
Alphatec Spine, Inc. | Address: 5818 El Camino Real, Carlsbad, California 92008, USA 
www.alphatecspine.com | Send Inquiry | Phone: +1-(760)-431-9286, 800-922-1356
FDA Registration: 2027467
Products: Anterior Cervical Plating System, Disposable Aspiration and Injection Needle (FDA Code: GAA), Bone Fixation Nail (FDA Code: JDS), Bone Fixation Plate (FDA Code: HRS), Bone Fixation Screw (FDA Code: HWC), Cervical Intervertebral Fusion Device With Bone Graft (FDA Code: ODP), ...
Alphatec Spine, Inc. is a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, primarily focused on the aging spine. We have more...
www.alphatecspine.com | Send Inquiry | Phone: +1-(760)-431-9286, 800-922-1356
FDA Registration: 2027467
Products: Anterior Cervical Plating System, Disposable Aspiration and Injection Needle (FDA Code: GAA), Bone Fixation Nail (FDA Code: JDS), Bone Fixation Plate (FDA Code: HRS), Bone Fixation Screw (FDA Code: HWC), Cervical Intervertebral Fusion Device With Bone Graft (FDA Code: ODP), ...
Alphatec Spine, Inc. is a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, primarily focused on the aging spine. We have more...
Tab Surgical Instruments, Inc. | Address: 371 E. Street, Chula Vista, California 91910, USA
Phone: +1-(619)-4221348
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Scalpel Blade (FDA Code: GES), General Surgical Scissors (FDA Code: LRW), Manual Osteotome (FDA Code: GFI), Manual Surgical Chisel (FDA Code: FZO), ...
Tab Surgical Instruments, Inc. specializes in the production of surgical products. Our product line comprises of caliper, curette, ENT speculum holder, needle holder, forceps, cannula, spatula, surgic more...
Phone: +1-(619)-4221348
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Scalpel Blade (FDA Code: GES), General Surgical Scissors (FDA Code: LRW), Manual Osteotome (FDA Code: GFI), Manual Surgical Chisel (FDA Code: FZO), ...
Tab Surgical Instruments, Inc. specializes in the production of surgical products. Our product line comprises of caliper, curette, ENT speculum holder, needle holder, forceps, cannula, spatula, surgic more...
G Hartzell & Son | Address: 2372 Stanwell Circle, Concord, California 94520, USA
www.ghartzellandson.com | Send Inquiry | Phone: +001-(800)-950-2206
FDA Registration: 2910921 Year Established: 1935 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: CE Certified
Products: Curettes, Forceps (FDA Code: HTD), Retractors, Scissors, Biopsy Punches (FDA Code: FCI), Extractors, ...
G. Hartzell & Son develops precision crafted dental and surgical instruments. We offer a very broad line of dental & surgical instruments and assemble conventional non-removable tipped periodontal ins more...
www.ghartzellandson.com | Send Inquiry | Phone: +001-(800)-950-2206
FDA Registration: 2910921 Year Established: 1935 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: CE Certified
Products: Curettes, Forceps (FDA Code: HTD), Retractors, Scissors, Biopsy Punches (FDA Code: FCI), Extractors, ...
G. Hartzell & Son develops precision crafted dental and surgical instruments. We offer a very broad line of dental & surgical instruments and assemble conventional non-removable tipped periodontal ins more...
Alero, Inc. | Address: 1550 Consumer Circle, Corona, California 92880, USA
www.aleroinc.com | Send Inquiry | Phone: +1-(951)-273-7890
Products: Forceps (FDA Code: HTD), Blood pressure Cuffs (FDA Code: DXQ), Precordial Chestpieces, Laryngoscope Blade, Disposable Laryngoscope Blades, Color Coded Guedel Airways, ...
Alero, Inc. offers medical products. Our products include breathing circuits, laryngoscope blades, handles, connectors & adapters, emergency airway code kit, veterinary blades, stylettes, forceps, che more...
www.aleroinc.com | Send Inquiry | Phone: +1-(951)-273-7890
Products: Forceps (FDA Code: HTD), Blood pressure Cuffs (FDA Code: DXQ), Precordial Chestpieces, Laryngoscope Blade, Disposable Laryngoscope Blades, Color Coded Guedel Airways, ...
Alero, Inc. offers medical products. Our products include breathing circuits, laryngoscope blades, handles, connectors & adapters, emergency airway code kit, veterinary blades, stylettes, forceps, che more...
Sunmed USA LLC. | Address: 841 Apollo Street, Suite 334, El Segundo, California 90245, USA
Phone: +1-(310)-531-8222
Products: Adhesive Bandages (FDA Code: KGX), Elastic Adhesive Bandages, Non-Adhesive Bandages, Flexible Fabric Adhesive Bandages, Adhesive Bandage Strip, Heat and Moisture Condenser (FDA Code: BYD), ...
Sunmed USA LLC. is a provider of adhesive bandages, flexible fabric adhesive bandages, and pocket size resuscitation devices. more...
Phone: +1-(310)-531-8222
Products: Adhesive Bandages (FDA Code: KGX), Elastic Adhesive Bandages, Non-Adhesive Bandages, Flexible Fabric Adhesive Bandages, Adhesive Bandage Strip, Heat and Moisture Condenser (FDA Code: BYD), ...
Sunmed USA LLC. is a provider of adhesive bandages, flexible fabric adhesive bandages, and pocket size resuscitation devices. more...
CP Medical, Inc. | Address: 21622 Surveyor Circle, Huntington Beach, California 92646, USA
www.cpmednet.com | Send Inquiry | Phone: +1-(714)-969-6818, 800-669-6973
FDA Registration: 3012164473 Year Established: 1981 Annual Revenues: USD 1-5 Million
Products: Clamps, Blood Tubing Sets, Broviac catheters, Back Supports, Blood Administration Sets, Bedpan (FDA Code: FOB), ...
CP Medical, Inc. specializes in offering hemodialysis solutions, powders and ancillary products to dialysis in the healthcare industry. We also offer a variety of modesty garments for visual imaging a more...
www.cpmednet.com | Send Inquiry | Phone: +1-(714)-969-6818, 800-669-6973
FDA Registration: 3012164473 Year Established: 1981 Annual Revenues: USD 1-5 Million
Products: Clamps, Blood Tubing Sets, Broviac catheters, Back Supports, Blood Administration Sets, Bedpan (FDA Code: FOB), ...
CP Medical, Inc. specializes in offering hemodialysis solutions, powders and ancillary products to dialysis in the healthcare industry. We also offer a variety of modesty garments for visual imaging a more...
Biomedical USA, Inc. | Address: 4450 Glen Street, La Mesa, California 91941, USA
Phone: +1-(619)-7508229
Products: Forceps (FDA Code: HTD), Skin Marker (FDA Code: FZZ), General & Plastic Surgery Surgical Cannula (FDA Code: GEA), Manual Surgical Chisel (FDA Code: FZO), Surgical Hammer (FDA Code: FZY), Ophthalmic Hook (FDA Code: HNQ), ...
Biomedical USA, Inc. specializes in surgical hammer, skin marker, ophthalmic hook, manual surgical chisel and forceps. more...
Phone: +1-(619)-7508229
Products: Forceps (FDA Code: HTD), Skin Marker (FDA Code: FZZ), General & Plastic Surgery Surgical Cannula (FDA Code: GEA), Manual Surgical Chisel (FDA Code: FZO), Surgical Hammer (FDA Code: FZY), Ophthalmic Hook (FDA Code: HNQ), ...
Biomedical USA, Inc. specializes in surgical hammer, skin marker, ophthalmic hook, manual surgical chisel and forceps. more...
Pfm Medical, Inc | Address: 2605 Temple Heights Drive, Suite A, Oceanside, California 92056, USA
www.pfmmedical.com | Send Inquiry | Phone: +1-(760)-7588749
FDA Registration: 3013666218 Quality: ISO 13485 Certified
Products: Embolectomy Catheters (FDA Code: DXE), AC-Powered Portable Ward Use Suction Apparatus (FDA Code: JCX), Operating Room Scrub Brush (FDA Code: GEC), Implanted Subcutaneous Intravascular Port & Catheter (FDA Code: LJT), Intravenous Administration Kit (FDA Code: FPA), Therapeutic Intravascular Catheter (FDA Code: LJS), ...
Pfm Medical, Inc specializes in products such as EZ Huber®, pfm PICC Catheters, and interventional cardiology. The EZ huber isolates the caregiver from harmful patient fluids and oncology drug spl more...
www.pfmmedical.com | Send Inquiry | Phone: +1-(760)-7588749
FDA Registration: 3013666218 Quality: ISO 13485 Certified
Products: Embolectomy Catheters (FDA Code: DXE), AC-Powered Portable Ward Use Suction Apparatus (FDA Code: JCX), Operating Room Scrub Brush (FDA Code: GEC), Implanted Subcutaneous Intravascular Port & Catheter (FDA Code: LJT), Intravenous Administration Kit (FDA Code: FPA), Therapeutic Intravascular Catheter (FDA Code: LJS), ...
Pfm Medical, Inc specializes in products such as EZ Huber®, pfm PICC Catheters, and interventional cardiology. The EZ huber isolates the caregiver from harmful patient fluids and oncology drug spl more...
H & H Co. | Address: 4435 East Airport Dr., #108, Ontario, California 91761, USA
www.hhco.net | Send Inquiry | Phone: +1-(909)-390-0373, 800-491-9989
FDA Registration: 2085199 Year Established: 1985
Products: Elevators, Calipers, Extraction Forceps, Fiber Optic Head Lamp, Micro Blade, Implant Surgery Instrument, ...
H & H Co. specializes in oral & maxillofacial surgery, periodontal, micro surgery and implant instruments. We also deal with quartz halogen & fiber optic headlamp systems, reconditioning & retipping o more...
www.hhco.net | Send Inquiry | Phone: +1-(909)-390-0373, 800-491-9989
FDA Registration: 2085199 Year Established: 1985
Products: Elevators, Calipers, Extraction Forceps, Fiber Optic Head Lamp, Micro Blade, Implant Surgery Instrument, ...
H & H Co. specializes in oral & maxillofacial surgery, periodontal, micro surgery and implant instruments. We also deal with quartz halogen & fiber optic headlamp systems, reconditioning & retipping o more...
SybronEndo Corporation | Address: 1717 West Collins Avenue, Orange, California 92867, USA
www.sybronendo.com | Send Inquiry | Phone: +1-(800)-346-3636
Annual Revenues: USD 10-25 Million Quality: ISO 9000 Certified
Products: Curettes, Forceps (FDA Code: HTD), Retractors, Scissors, General Medical Supplies, Biopsy Forceps, Internal Jugular Approach 7, ...
SybronEndo Corporation offers the most comprehensive portfolio of endodontic products. SlickGel ES is composed of both urea peroxide and an aqueous solution of EDTA. The gel provides a lubricating med more...
www.sybronendo.com | Send Inquiry | Phone: +1-(800)-346-3636
Annual Revenues: USD 10-25 Million Quality: ISO 9000 Certified
Products: Curettes, Forceps (FDA Code: HTD), Retractors, Scissors, General Medical Supplies, Biopsy Forceps, Internal Jugular Approach 7, ...
SybronEndo Corporation offers the most comprehensive portfolio of endodontic products. SlickGel ES is composed of both urea peroxide and an aqueous solution of EDTA. The gel provides a lubricating med more...
Amsino International, Inc | Address: 855 Towne Center Drive, Pomona, California 91767, USA
www.amsino.com | Send Inquiry | Phone: +1-(906)-626-5888
FDA Registration: 2085175 Year Established: 1993 Annual Revenues: USD 25-50 Million Employee Count: ~500 Quality: ISO 9001, CE Certified
Products: Adult Tracheostomy Mask, Aspirators, Disposable Leg Bags, Cervical Scrapers, Central Line Dressing Change Trays, Coiled Sterile Suction Catheter, ...
Amsino International, Inc is an ISO 9001 certified company. We manufacture disposable medical products. We specialize in urology, general feeding with irrigation, IV therapy products, surgical, genera more...
www.amsino.com | Send Inquiry | Phone: +1-(906)-626-5888
FDA Registration: 2085175 Year Established: 1993 Annual Revenues: USD 25-50 Million Employee Count: ~500 Quality: ISO 9001, CE Certified
Products: Adult Tracheostomy Mask, Aspirators, Disposable Leg Bags, Cervical Scrapers, Central Line Dressing Change Trays, Coiled Sterile Suction Catheter, ...
Amsino International, Inc is an ISO 9001 certified company. We manufacture disposable medical products. We specialize in urology, general feeding with irrigation, IV therapy products, surgical, genera more...
International Hospital Supply Co. | Address: 6914 Canby Ave., Ste. 105, Reseda, California 91335-8741, USA
/www.internationalhospitalsupply.com | Send Inquiry | Phone: +1-(818)-996-0600, 800-398-9450
Year Established: 1977 Annual Revenues: USD 1-5 Million Quality: ISO 9002 Certified
Products: Forceps (FDA Code: HTD), Tissue Forceps, Adson Tissue Forceps, Metzenbaum Scissors, Mosquito Forceps, Gynaecological Scissors, ...
International Hospital Supply Co. provides sterile surgical products, latex-free, vinyl, non-sterile exam, latex, and latex-free vinyl gloves, custom trays, bone drill, bone fixation nail, collapsible more...
/www.internationalhospitalsupply.com | Send Inquiry | Phone: +1-(818)-996-0600, 800-398-9450
Year Established: 1977 Annual Revenues: USD 1-5 Million Quality: ISO 9002 Certified
Products: Forceps (FDA Code: HTD), Tissue Forceps, Adson Tissue Forceps, Metzenbaum Scissors, Mosquito Forceps, Gynaecological Scissors, ...
International Hospital Supply Co. provides sterile surgical products, latex-free, vinyl, non-sterile exam, latex, and latex-free vinyl gloves, custom trays, bone drill, bone fixation nail, collapsible more...
Danville Materials, Inc. | Address: 3420 Fostoria Way Suite A-200, San Ramon, California 94583, USA
www.danvillematerials.com | Send Inquiry | Phone: +1-(800)-827-7940
Products: Forceps (FDA Code: HTD), Retractors, General Medical Supplies, Biopsy Forceps, Internal Jugular Approach 7, Alligator Forceps, Obstetrical Forceps (FDA Code: HDA), ...
Danville Materials, Inc. manufactures a wide range of dental materials. We are an ISO 9002 certified company. We offer Aria, a highly filled reinforced microfill flowable composite that is light-cured more...
www.danvillematerials.com | Send Inquiry | Phone: +1-(800)-827-7940
Products: Forceps (FDA Code: HTD), Retractors, General Medical Supplies, Biopsy Forceps, Internal Jugular Approach 7, Alligator Forceps, Obstetrical Forceps (FDA Code: HDA), ...
Danville Materials, Inc. manufactures a wide range of dental materials. We are an ISO 9002 certified company. We offer Aria, a highly filled reinforced microfill flowable composite that is light-cured more...
San Pablo Commercial Corp. | Address: 45 W Easy Street, Suite 25, Simi Valley, California 93065, USA
www.shop.sanpablocom.com | Send Inquiry | Phone: +1-(805)-583-8883
FDA Registration: 3005165456
Products: Adhesive Bandages (FDA Code: KGX), Alcohol Prep Pad, Cold & Hot Packs, Adult Diaper, Briefs Adult Diapers, Adhesive Tape, ...
San Pablo Commercial Corp. deals with antiseptics, adult diapers, gauze, compresses & dressings, hot & cold packs, tapes and wrap products. Our antiseptic products are used to clean the area around th more...
www.shop.sanpablocom.com | Send Inquiry | Phone: +1-(805)-583-8883
FDA Registration: 3005165456
Products: Adhesive Bandages (FDA Code: KGX), Alcohol Prep Pad, Cold & Hot Packs, Adult Diaper, Briefs Adult Diapers, Adhesive Tape, ...
San Pablo Commercial Corp. deals with antiseptics, adult diapers, gauze, compresses & dressings, hot & cold packs, tapes and wrap products. Our antiseptic products are used to clean the area around th more...
Medtronic Spine LLC | Address: 1221 Crossman Ave., Sunnyvale, California 94089, USA
www.medtronicspine.com | Send Inquiry | Phone: +1-(408)-548-6500, 877-690-5353
FDA Registration: 2953769 Year Established: 1994
Products: Drill Bit (FDA Code: HTW), Drill Bits & Bone Taps, Cannulated Drill Bit, Anesthetic Conduction Needle with/without Introducer (FDA Code: BSP), Balloon Inflation Syringe (FDA Code: MAV), Disposable Aspiration and Injection Needle (FDA Code: GAA), ...
Medtronic Spine LLC offers online resource for neck pain, back pain, spinal health and treatment options for the same. Our cervical products for spinal surgery include plates, tissues and interbodies more...
www.medtronicspine.com | Send Inquiry | Phone: +1-(408)-548-6500, 877-690-5353
FDA Registration: 2953769 Year Established: 1994
Products: Drill Bit (FDA Code: HTW), Drill Bits & Bone Taps, Cannulated Drill Bit, Anesthetic Conduction Needle with/without Introducer (FDA Code: BSP), Balloon Inflation Syringe (FDA Code: MAV), Disposable Aspiration and Injection Needle (FDA Code: GAA), ...
Medtronic Spine LLC offers online resource for neck pain, back pain, spinal health and treatment options for the same. Our cervical products for spinal surgery include plates, tissues and interbodies more...
Pare Surgical, Inc. | Address: 7332 South Alton Way, Unit H, Centennial, Colorado 80112, USA
www.paresurgical.com | Send Inquiry | Phone: +1-(303)-689-0187
Year Established: 1994 Annual Revenues: < USD 1 Million Quality: ISO 9002, CE Certified
Products: Forceps (FDA Code: HTD), Surgical Sutures, Endoscopic Suturing Devices (FDA Code: MFJ), Suturing Instrument, General & Plastic Surgery Laparoscope (FDA Code: GCJ), Endoscope Accessories (FDA Code: KOG), ...
Pare Surgical, Inc. is a medical device company. We develop minimally invasive surgical instruments for hospital and surgical centers. Our products are reusable and disposable Quick stitch & gi-stitch more...
www.paresurgical.com | Send Inquiry | Phone: +1-(303)-689-0187
Year Established: 1994 Annual Revenues: < USD 1 Million Quality: ISO 9002, CE Certified
Products: Forceps (FDA Code: HTD), Surgical Sutures, Endoscopic Suturing Devices (FDA Code: MFJ), Suturing Instrument, General & Plastic Surgery Laparoscope (FDA Code: GCJ), Endoscope Accessories (FDA Code: KOG), ...
Pare Surgical, Inc. is a medical device company. We develop minimally invasive surgical instruments for hospital and surgical centers. Our products are reusable and disposable Quick stitch & gi-stitch more...
Comeg USA | Address: 7808 Cherry Creek Drive S., Unit 213, Denver, Colorado 80231, USA
Phone: +1-(720)-213-0123/800-248-5799
Year Established: 1989 Annual Revenues: < USD 1 Million Employee Count: ~20
Products: General Surgical Instruments, Instruments surgical, Common Surgical Instrument, Endoscopes, Flexible Endoscopes (FDA Code: GCQ), Rigid Endoscopes (FDA Code: GCM), ...
Comeg USA offers a complete line of autoclavable rigid scopes, surgical instruments & accessories, and provides service for rigid & flexible endoscopes, hand & powered instruments, video equipment & b more...
Phone: +1-(720)-213-0123/800-248-5799
Year Established: 1989 Annual Revenues: < USD 1 Million Employee Count: ~20
Products: General Surgical Instruments, Instruments surgical, Common Surgical Instrument, Endoscopes, Flexible Endoscopes (FDA Code: GCQ), Rigid Endoscopes (FDA Code: GCM), ...
Comeg USA offers a complete line of autoclavable rigid scopes, surgical instruments & accessories, and provides service for rigid & flexible endoscopes, hand & powered instruments, video equipment & b more...
Spine Wave, Inc. | Address: Three Enterprise Drive, Suite 210, Shelton, Connecticut 06484, USA
www.spinewave.com | Send Inquiry | Phone: +1-(203)-944-9494, 877-844-4225
FDA Registration: 3004638600
Products: Pedicle Screw System, Vertebral Body Replacement System, Medical Devices, Disposable Aspiration and Injection Needle (FDA Code: GAA), General & Plastic Surgery Surgical Cannula (FDA Code: GEA), Spinal Vertebral Body Replacement Device (FDA Code: MQP), ...
Spine Wave, Inc. deals with the development and delivery of innovative medical devices for the treatment of spinal disorders. Our trade mark products are Spine Wave™, StaXx®, CapSure®, a more...
www.spinewave.com | Send Inquiry | Phone: +1-(203)-944-9494, 877-844-4225
FDA Registration: 3004638600
Products: Pedicle Screw System, Vertebral Body Replacement System, Medical Devices, Disposable Aspiration and Injection Needle (FDA Code: GAA), General & Plastic Surgery Surgical Cannula (FDA Code: GEA), Spinal Vertebral Body Replacement Device (FDA Code: MQP), ...
Spine Wave, Inc. deals with the development and delivery of innovative medical devices for the treatment of spinal disorders. Our trade mark products are Spine Wave™, StaXx®, CapSure®, a more...
Septodont, Inc. | Address: 245 Quigley Blvd Ste C, New Castle, Delaware 19720, USA
www.septodontinc.com | Send Inquiry | Phone: +1-(302)-328-1102, (800)-872-8305
FDA Registration: 1721729
Products: Forceps (FDA Code: HTD), Anesthetics, Masks & Faceshields, General Medical Supplies, Skin Creams & Lotions, Biopsy Forceps, Internal Jugular Approach 7, ...
Septodont, Inc. manufactures & distributes dental local anesthetics. We offer a full line of dental local anesthetic products in 100% latex free dental cartridges. Our petite syringe is designed for d more...
www.septodontinc.com | Send Inquiry | Phone: +1-(302)-328-1102, (800)-872-8305
FDA Registration: 1721729
Products: Forceps (FDA Code: HTD), Anesthetics, Masks & Faceshields, General Medical Supplies, Skin Creams & Lotions, Biopsy Forceps, Internal Jugular Approach 7, ...
Septodont, Inc. manufactures & distributes dental local anesthetics. We offer a full line of dental local anesthetic products in 100% latex free dental cartridges. Our petite syringe is designed for d more...
Hi Tech International Group Inc | Address: 4301 Oak Circle, Suite 18, Boca Raton, Florida 33431, USA
www.htig.com | Send Inquiry | Phone: +1-(561)-367-8760
Products: Consulting Services, Medical Ultrasound Devices, Nuclear Medicine, MRI Reselling Service, Endoscopy Consulting, Radiology Tables, ...
Hi Tech International Group Inc distributes used and refurbished diagnostic medical systems. We offer refurbished X-ray system, CT scanners, ultrasound system, nuclear medicine, MRI, CT scanners and m more...
www.htig.com | Send Inquiry | Phone: +1-(561)-367-8760
Products: Consulting Services, Medical Ultrasound Devices, Nuclear Medicine, MRI Reselling Service, Endoscopy Consulting, Radiology Tables, ...
Hi Tech International Group Inc distributes used and refurbished diagnostic medical systems. We offer refurbished X-ray system, CT scanners, ultrasound system, nuclear medicine, MRI, CT scanners and m more...
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FDA Code / Regulation: HTD / 878.4800
A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 878.9.
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