Scalpel Blade Suppliers
Limit companies to: Worldwide USA
Welltek Instruments | Address: Sector G, Street 1A, Building No. 248, Model Town, West Ugoki, Sialkot 51050, Pakistan
www.welltekinstruments.com | Send Inquiry | Phone: +92-(523)-510 393
Products: Forceps (FDA Code: HTD), Scalpels, Scissors, Electric Instrument Sterilizer, Amputation knives, Autopsy Knives, ...
Welltek Instruments is a manufacturer of single use & reusable surgical instruments, and stainless steel hollow wares. Our single use surgical instruments include scalpels, operating scissors, forceps more...
www.welltekinstruments.com | Send Inquiry | Phone: +92-(523)-510 393
Products: Forceps (FDA Code: HTD), Scalpels, Scissors, Electric Instrument Sterilizer, Amputation knives, Autopsy Knives, ...
Welltek Instruments is a manufacturer of single use & reusable surgical instruments, and stainless steel hollow wares. Our single use surgical instruments include scalpels, operating scissors, forceps more...
Quality Concept (Pvt) Ltd. | Address: P.O. Box 2424, Small Industrial Estate, Sialkot, Pakistan
www.quality-concept.com | Send Inquiry | Phone: +92-(52)-3255528
FDA Registration: 3002090132
Products: Forceps (FDA Code: HTD), Ear Curette (FDA Code: JYG), Circumcision Clamps (FDA Code: HFX), Circumcision Clamp, Ring (FDA Code: HFX), General & Plastic Surgery Forceps (FDA Code: GEN), General & Plastic Surgery Surgical Hook (FDA Code: GDG), ...
Quality Concept (Pvt) Ltd. is a manufacturer and exporter of surgical, dental and laboratory instruments. Our product line includes many different kinds of patterns of precision-crafted stainless stee more...
www.quality-concept.com | Send Inquiry | Phone: +92-(52)-3255528
FDA Registration: 3002090132
Products: Forceps (FDA Code: HTD), Ear Curette (FDA Code: JYG), Circumcision Clamps (FDA Code: HFX), Circumcision Clamp, Ring (FDA Code: HFX), General & Plastic Surgery Forceps (FDA Code: GEN), General & Plastic Surgery Surgical Hook (FDA Code: GDG), ...
Quality Concept (Pvt) Ltd. is a manufacturer and exporter of surgical, dental and laboratory instruments. Our product line includes many different kinds of patterns of precision-crafted stainless stee more...
Excite Surgical Corporation | Address: 1-A Shahab Pura Ogoki Road Small, Industrial Estate, P.O. Box # 2959, Sialkot, Pakistan
www.excitesurgical.com | Send Inquiry | Phone: +92-(321)-7191539
Products: Bone Holding Forceps, Biopsy Forceps, Surgical Bone Holding forceps, Bone Cutting Forceps, Bone Cutting Forceps straight, Ear & Nasal Dressing Forceps, ...
Excite Surgical Corporation is a diversified medical instruments manufacturing company. We develop, manufacture and market instruments for use in a variety of applications. Our products include clinic more...
www.excitesurgical.com | Send Inquiry | Phone: +92-(321)-7191539
Products: Bone Holding Forceps, Biopsy Forceps, Surgical Bone Holding forceps, Bone Cutting Forceps, Bone Cutting Forceps straight, Ear & Nasal Dressing Forceps, ...
Excite Surgical Corporation is a diversified medical instruments manufacturing company. We develop, manufacture and market instruments for use in a variety of applications. Our products include clinic more...
Spectrum Surgical Supplies | Address: 4/33 Ch. Fazal Din St., Ahmed Pura, Sialkot 51310, Pakistan
Phone: +92-(703)-6283591
FDA Registration: 3005374323
Products: ENT Nasal Gouge (FDA Code: KAQ), Soft Ear Speculum (FDA Code: EPY), Ear Speculum (FDA Code: EPY), ENT Elevator (FDA Code: KAD), Microsurgical Ear Hook (FDA Code: JYL), Nasal Knife (FDA Code: KAS), ...
Spectrum Surgical Supplies offers medical surgical instruments. Our product line comprises of ENT mirror, ENT elevator, forceps, amputation knife, ENT nasal gouge and general use surgical curettes. We more...
Phone: +92-(703)-6283591
FDA Registration: 3005374323
Products: ENT Nasal Gouge (FDA Code: KAQ), Soft Ear Speculum (FDA Code: EPY), Ear Speculum (FDA Code: EPY), ENT Elevator (FDA Code: KAD), Microsurgical Ear Hook (FDA Code: JYL), Nasal Knife (FDA Code: KAS), ...
Spectrum Surgical Supplies offers medical surgical instruments. Our product line comprises of ENT mirror, ENT elevator, forceps, amputation knife, ENT nasal gouge and general use surgical curettes. We more...
Planner Products | Address: Pacca Garah, Moh. Islam Nagar, Kashmir, Road, Street Mahboob Public School, Sialkot, PK-PB 51310, Pakistan
www.planner-products.net | Send Inquiry | Phone: +92-(52)-4293264
Products: Forceps (FDA Code: HTD), Non Rigid Laryngoscope (FDA Code: CAL), Rigid Laryngoscope (FDA Code: CCW), General Surgical Scissors (FDA Code: LRW), Metal Vaginal Speculum (FDA Code: HDF), Orthopedic Needle Holder (FDA Code: HXK), ...
Planner Products specializes in manufacturing surgical, dental and diagnostic instruments. Our surgical instruments includes scalpel handles, super cut scissors, hemostatic forceps, tissue forceps, to more...
www.planner-products.net | Send Inquiry | Phone: +92-(52)-4293264
Products: Forceps (FDA Code: HTD), Non Rigid Laryngoscope (FDA Code: CAL), Rigid Laryngoscope (FDA Code: CCW), General Surgical Scissors (FDA Code: LRW), Metal Vaginal Speculum (FDA Code: HDF), Orthopedic Needle Holder (FDA Code: HXK), ...
Planner Products specializes in manufacturing surgical, dental and diagnostic instruments. Our surgical instruments includes scalpel handles, super cut scissors, hemostatic forceps, tissue forceps, to more...
Jazal Group | Address: Kot Borra, P.O Box, Kotli Loharan (west), Sialkot, Punjab 51220, Pakistan
www.jazalgroup.com | Send Inquiry | Phone: +92-(52)-811 3619
Products: Dressing Forceps, Eye Speculum, Instruments surgical, Hospital Furniture, Micro Forceps, Surgical Holloware Instrument, ...
Jazal Group manufactures & exports surgical, dental, hollow ware, veterinary and titanium instruments. We also offer hospital clothing and furniture. Our surgical instruments include bone & plaster cu more...
www.jazalgroup.com | Send Inquiry | Phone: +92-(52)-811 3619
Products: Dressing Forceps, Eye Speculum, Instruments surgical, Hospital Furniture, Micro Forceps, Surgical Holloware Instrument, ...
Jazal Group manufactures & exports surgical, dental, hollow ware, veterinary and titanium instruments. We also offer hospital clothing and furniture. Our surgical instruments include bone & plaster cu more...
Hygeia Surgico | Address: Ramtalia road, Sialkot, Punjab 51310, Pakistan
www.hygeiasurgico.com | Send Inquiry | Phone: +92-(52)-4567258
Year Established: 1992 Quality: CE Mark Certified
Products: Anesthesia, Diagnostic Instruments, Bone Cutting Forceps, Dressing Scissors, Extraction Forceps, Dental Cement Spatulas, ...
Hygeia Surgico manufactures surgical, dental, gynecology, orthodontic and orthopedics instruments. Our surgical instruments include diagnostic instruments, anesthetic instruments, scalpels & blades, o more...
www.hygeiasurgico.com | Send Inquiry | Phone: +92-(52)-4567258
Year Established: 1992 Quality: CE Mark Certified
Products: Anesthesia, Diagnostic Instruments, Bone Cutting Forceps, Dressing Scissors, Extraction Forceps, Dental Cement Spatulas, ...
Hygeia Surgico manufactures surgical, dental, gynecology, orthodontic and orthopedics instruments. Our surgical instruments include diagnostic instruments, anesthetic instruments, scalpels & blades, o more...
Landen Tools Inc. | Address: Khan Street Amanat Pura, Jammu Road, Sialkot, Punjab 51310, Pakistan
www.landentools.com | Send Inquiry | Phone: +92-(52)-4581319
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
Landen Tools Inc. specializes in producing custom medical and beauty tools. Our medical products include anesthesia instruments, diagnostic instruments, forceps and general instruments. We offer medic more...
www.landentools.com | Send Inquiry | Phone: +92-(52)-4581319
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
Landen Tools Inc. specializes in producing custom medical and beauty tools. Our medical products include anesthesia instruments, diagnostic instruments, forceps and general instruments. We offer medic more...
A.L.M. Surgicare | Address: 143/c. Fatima Jinnah Rd., Industrial Estate, Sialkot, Punjab, Pakistan
www.almsurgicare.com | Send Inquiry | Phone: +92-(52)-3556039
Quality: IS0 9001:2000 Certified
Products: ENT Syringe (FDA Code: KCP), ENT Irrigation Syringe (FDA Code: KCP), Ear Speculum (FDA Code: EPY), Cuff Spreader (FDA Code: CBG), ENT Probe (FDA Code: KAK), Gastro-Urology Probe and Director (FDA Code: FGM), ...
A.L.M. Surgicare manufactures and exports reusable surgical & dental instruments, chiropody, pedicure & manicure instruments & ranges of tungsten carbide inserted scissors, needle holders & nail & wir more...
www.almsurgicare.com | Send Inquiry | Phone: +92-(52)-3556039
Quality: IS0 9001:2000 Certified
Products: ENT Syringe (FDA Code: KCP), ENT Irrigation Syringe (FDA Code: KCP), Ear Speculum (FDA Code: EPY), Cuff Spreader (FDA Code: CBG), ENT Probe (FDA Code: KAK), Gastro-Urology Probe and Director (FDA Code: FGM), ...
A.L.M. Surgicare manufactures and exports reusable surgical & dental instruments, chiropody, pedicure & manicure instruments & ranges of tungsten carbide inserted scissors, needle holders & nail & wir more...
Garana Industries Private Limited | Address: Chiristian Town, P.O.Box 785, Sialkot, Punjab 51310, Pakistan
www.garanaonline.com | Send Inquiry | Phone: +92-(52)-4267298, 4266944
FDA Registration: 3003759558 Quality: ISO 9002 Certified
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), General & Plastic Surgery Forceps (FDA Code: GEN), General & Plastic Surgery Surgical Clamp (FDA Code: GDJ), Surgical Hammer (FDA Code: FZY), Metal Vaginal Speculum (FDA Code: HDF), Surgical Pliers (FDA Code: HTC), ...
Garana Industries Private Limited is a manufacturer and exporter of surgical instruments as well as scissors of all kinds. Our surgical instruments include diagnostic stethoscope, bandage scissors, di more...
www.garanaonline.com | Send Inquiry | Phone: +92-(52)-4267298, 4266944
FDA Registration: 3003759558 Quality: ISO 9002 Certified
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), General & Plastic Surgery Forceps (FDA Code: GEN), General & Plastic Surgery Surgical Clamp (FDA Code: GDJ), Surgical Hammer (FDA Code: FZY), Metal Vaginal Speculum (FDA Code: HDF), Surgical Pliers (FDA Code: HTC), ...
Garana Industries Private Limited is a manufacturer and exporter of surgical instruments as well as scissors of all kinds. Our surgical instruments include diagnostic stethoscope, bandage scissors, di more...
Glorious Mercantile Corp. (Pvt) Ltd. | Address: 15 - A, Small Industrial Estate, Sialkot, Punjab, Pakistan
www.glorious-group.com | Send Inquiry | Phone: +92-(52)-3256017, 3255528
FDA Registration: 8040263 Quality: ISO 9001:2000 and ISO 13485:2003 Certified
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
Glorious Mercantile Corp. (Pvt) Ltd. is a manufacturer and exporter of surgical, dental, veterinary, laboratory and all related beauty health care instruments to doctors, hospitals & health service ag more...
www.glorious-group.com | Send Inquiry | Phone: +92-(52)-3256017, 3255528
FDA Registration: 8040263 Quality: ISO 9001:2000 and ISO 13485:2003 Certified
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
Glorious Mercantile Corp. (Pvt) Ltd. is a manufacturer and exporter of surgical, dental, veterinary, laboratory and all related beauty health care instruments to doctors, hospitals & health service ag more...
The Mughal Surgical (Pvt) Ltd | Address: C-95 Industrial Estate, P.O.Box 274, Punjab Province, Sialkot, Punjab 51340, Pakistan
www.mughalsurgical.com | Send Inquiry | Phone: +92-(52)-355-3671
Quality: ISO 9001:2008, ISO 13485:2003, CE Certified
Products: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Episiotomy Scissors (FDA Code: HDK), Flexible Depth Gauge (FDA Code: HTJ), Biopsy Forceps Cover (FDA Code: FFF), Ophthalmic Trocar Cannula (FDA Code: NGY), ...
The Mughal Surgical (Pvt)Ltd provides instruments to surgical, dental, veterinary and beauty care fields. Our surgical products include scalpels, scissors, dressing & tissue forceps, retractors, needl more...
www.mughalsurgical.com | Send Inquiry | Phone: +92-(52)-355-3671
Quality: ISO 9001:2008, ISO 13485:2003, CE Certified
Products: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Episiotomy Scissors (FDA Code: HDK), Flexible Depth Gauge (FDA Code: HTJ), Biopsy Forceps Cover (FDA Code: FFF), Ophthalmic Trocar Cannula (FDA Code: NGY), ...
The Mughal Surgical (Pvt)Ltd provides instruments to surgical, dental, veterinary and beauty care fields. Our surgical products include scalpels, scissors, dressing & tissue forceps, retractors, needl more...
Pearlite Enterprises | Address: Defence Road, Sialkot, Punjab 51310, Pakistan
www.pearlitesurgical.com | Send Inquiry | Phone: +92-(52)-3256133
Products: Retractors, Scalpels, Dressing Forceps, Haemostatic Forceps, Needle Holders & Scissors, Orthopedic Instruments, ...
Pearlite Enterprises manufactures surgical and medical devices. Our surgical instruments are developed for diagnostics, scalpel holders, scissors, haemostatic forceps, dressing forceps, needle holders more...
www.pearlitesurgical.com | Send Inquiry | Phone: +92-(52)-3256133
Products: Retractors, Scalpels, Dressing Forceps, Haemostatic Forceps, Needle Holders & Scissors, Orthopedic Instruments, ...
Pearlite Enterprises manufactures surgical and medical devices. Our surgical instruments are developed for diagnostics, scalpel holders, scissors, haemostatic forceps, dressing forceps, needle holders more...
AAKK Surgical Corporation | Address: Khan Mahal Road, Kamela, Sialkot, Punjab 51310, Pakistan
www.aakksurgical.com | Send Inquiry | Phone: +92-(52)-4600238
Year Established: 2006 Quality: ISO 9001, ISO 13485, ISO 7376, CE Mark and GMP-FDA Certified
Products: Articulating Tip Laryngoscopes, Conventional Laryngoscopes, Airway Management, Child Laryngoscope Lamp, Adult Laryngoscope Lamp, Airway Management Intubation Kit, ...
AAKK Surgical Corporation manufactures and exports laryngoscope, otoscope, anesthesia/diagnostic instruments and surgical instruments. Our products are manufactured using stainless steel as per ASTM a more...
www.aakksurgical.com | Send Inquiry | Phone: +92-(52)-4600238
Year Established: 2006 Quality: ISO 9001, ISO 13485, ISO 7376, CE Mark and GMP-FDA Certified
Products: Articulating Tip Laryngoscopes, Conventional Laryngoscopes, Airway Management, Child Laryngoscope Lamp, Adult Laryngoscope Lamp, Airway Management Intubation Kit, ...
AAKK Surgical Corporation manufactures and exports laryngoscope, otoscope, anesthesia/diagnostic instruments and surgical instruments. Our products are manufactured using stainless steel as per ASTM a more...
Goval Internacional S.A. De C.V. | Address: Washington 3000 Pte., Col. Deportivo Obispado, Monterrey, MX-NLE 64040, Mexico
Products: ENT Forceps (FDA Code: KAE), Rigid Laryngoscope (FDA Code: CCW), Manual Stethoscope (FDA Code: LDE), Speculum Accessories (FDA Code: FXG), Low Power Binocular Loupe (FDA Code: HJH), Otoscopes (FDA Code: ERA), ...
Goval Internacional S.A. De C.V. is a provider of surgical and diagnostic equipments. more...
Products: ENT Forceps (FDA Code: KAE), Rigid Laryngoscope (FDA Code: CCW), Manual Stethoscope (FDA Code: LDE), Speculum Accessories (FDA Code: FXG), Low Power Binocular Loupe (FDA Code: HJH), Otoscopes (FDA Code: ERA), ...
Goval Internacional S.A. De C.V. is a provider of surgical and diagnostic equipments. more...
Able Global Healthcare Sdn. Bhd. | Address: B3-13 Taman Kasturi, Jalan Kasturi 6, P.O. Box 95, Batu 11, Cheras, Kuala Lumpur, Cheras Kuala Lumpur 43207, Malaysia
www.ableglobalhealthcare.com | Send Inquiry | Phone: +6-(3)-2169 6311
FDA Registration: 1057199 Year Established: 1993 Annual Revenues: USD 5-10 Million Employee Count: ~20 Quality: ISO 9000, ISO 9001, CE Certified
Products: Oxygen Masks (FDA Code: BYG), Holter ECG Monitors, Integrated Anesthesia Machines, ECG Monitor, New Or Used Disposable Examination Gowns and Capes, Operating Room Equipment Table Extensions, ...
Able Global Healthcare Sdn. Bhd. is a provider of medical diagnostic products. We offer products in many medicals sectors that include radiology, diagnostic, cardiology, surgeons products, ICU/CCU pro more...
www.ableglobalhealthcare.com | Send Inquiry | Phone: +6-(3)-2169 6311
FDA Registration: 1057199 Year Established: 1993 Annual Revenues: USD 5-10 Million Employee Count: ~20 Quality: ISO 9000, ISO 9001, CE Certified
Products: Oxygen Masks (FDA Code: BYG), Holter ECG Monitors, Integrated Anesthesia Machines, ECG Monitor, New Or Used Disposable Examination Gowns and Capes, Operating Room Equipment Table Extensions, ...
Able Global Healthcare Sdn. Bhd. is a provider of medical diagnostic products. We offer products in many medicals sectors that include radiology, diagnostic, cardiology, surgeons products, ICU/CCU pro more...
Ailee Co Ltd. | Address: 280-2 Hakjang-Dong, Sasang-Ku, Busan 617-844, Korea, Republic Of 
www.ailee.co.kr | Send Inquiry | Phone: +82-(051)-3226161
FDA Registration: 8040573
Products: Scalpel Handle (FDA Code: GDZ), Dissecting Scalpel Handle, Dissecting Scalpel Blades, Single Handed Scalpel Blade Remover, Titanium Beaver Scalpel Handle, Scalpel Blade (FDA Code: GES), ...
Ailee Co Ltd. manufactures disposable surgical instruments such as scalpel, suture needle, needled suture & non-needled suture, disposable scalpel, stainless steel scalpel blades, and sterile & non-st more...
www.ailee.co.kr | Send Inquiry | Phone: +82-(051)-3226161
FDA Registration: 8040573
Products: Scalpel Handle (FDA Code: GDZ), Dissecting Scalpel Handle, Dissecting Scalpel Blades, Single Handed Scalpel Blade Remover, Titanium Beaver Scalpel Handle, Scalpel Blade (FDA Code: GES), ...
Ailee Co Ltd. manufactures disposable surgical instruments such as scalpel, suture needle, needled suture & non-needled suture, disposable scalpel, stainless steel scalpel blades, and sterile & non-st more...
Bk Meditech Co., Ltd. | Address: #607 Instopia Bldg, Dokok Dong, Kangnam-ku, Seoul 467-23, Korea, Republic Of
www.bkmeditech.com | Phone: +82-(31)-3529135
FDA Registration: 3004176895
Products: Bone Taps (FDA Code: HWX), Laparoscopic Probes, Guiding Probes, Awl (FDA Code: HWJ), Bender (FDA Code: HXW), Compression Instrument (FDA Code: HWN), ...
Bk Meditech Co., Ltd. manufactures orthopaedic implants. Our products are Dyna spine, Dyna Extor arm, Dyna Extor finger, Dyna Extor limb and Dyna Extor wrist systems. Our Dyna spinal system features a more...
www.bkmeditech.com | Phone: +82-(31)-3529135
FDA Registration: 3004176895
Products: Bone Taps (FDA Code: HWX), Laparoscopic Probes, Guiding Probes, Awl (FDA Code: HWJ), Bender (FDA Code: HXW), Compression Instrument (FDA Code: HWN), ...
Bk Meditech Co., Ltd. manufactures orthopaedic implants. Our products are Dyna spine, Dyna Extor arm, Dyna Extor finger, Dyna Extor limb and Dyna Extor wrist systems. Our Dyna spinal system features a more...
Masakuni Co., Ltd. | Address: 1-5-26 Asahi, Kawaguchi 332-0001, Japan
Phone: +81-(048)-2-22-2641
Products: Dissecting Scalpel Blades, Single Handed Scalpel Blade Remover, Scalpel Blade (FDA Code: GES), ...
Masakuni Co., Ltd. is a manufacturer of scalpel blades for plastic surgery. more...
Phone: +81-(048)-2-22-2641
Products: Dissecting Scalpel Blades, Single Handed Scalpel Blade Remover, Scalpel Blade (FDA Code: GES), ...
Masakuni Co., Ltd. is a manufacturer of scalpel blades for plastic surgery. more...
Feather Safety Razor Co., Ltd. | Address: Feather Bldg. 5th FL., 5-2, Dojima 1-chome, Kita-ku, Osaka 530-0003, Japan
www.feather.co.jp | Send Inquiry | Phone: +81-(06)-6452-5518
FDA Registration: 9614636
Products: Blood Lancets, Blade Holders, Disposable Blades, Disposable Scalpels, Disposable Microtome Blade Holders, Disposable Microtome Blades, ...
Feather Safety Razor Co., Ltd. specializes in precision cutting tools. Our medical product categories are neurosurgery, surgery, otorhinolaryngology, pathology and opthamology. Our Feather neuro blade more...
www.feather.co.jp | Send Inquiry | Phone: +81-(06)-6452-5518
FDA Registration: 9614636
Products: Blood Lancets, Blade Holders, Disposable Blades, Disposable Scalpels, Disposable Microtome Blade Holders, Disposable Microtome Blades, ...
Feather Safety Razor Co., Ltd. specializes in precision cutting tools. Our medical product categories are neurosurgery, surgery, otorhinolaryngology, pathology and opthamology. Our Feather neuro blade more...
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FDA Code / Regulation: GES / 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.
