Scalpel Blade Suppliers
Limit companies to: Worldwide USA
Medisiss | Address: 2747 Sw 6th Street, Redmond, Oregon 97756, USA 
www.medisiss.com | Send Inquiry | Phone: +1-(541)-923-3310,866-866-7477
FDA Registration: 3032391
Products: Surgical Sterilizing Aids, Packaging, Instrument Cleaning System, Medical Devices, Instrument Maintenance & Refurbishing Service, Electrosurgical Cutting and Coagulation Device (FDA Code: GEI), ...
Medisiss is a registered third-party medical device reprocessor of single-use devices (SUDs).Our service list encompasses the cleaning, testing, refurbishing, sterilizing and packaging of both re-usab more...
www.medisiss.com | Send Inquiry | Phone: +1-(541)-923-3310,866-866-7477
FDA Registration: 3032391
Products: Surgical Sterilizing Aids, Packaging, Instrument Cleaning System, Medical Devices, Instrument Maintenance & Refurbishing Service, Electrosurgical Cutting and Coagulation Device (FDA Code: GEI), ...
Medisiss is a registered third-party medical device reprocessor of single-use devices (SUDs).Our service list encompasses the cleaning, testing, refurbishing, sterilizing and packaging of both re-usab more...
Lifeline First Aid LLC | Address: 6713 Sw Bonita Rd., Suite 206, Tigard, Oregon 97224, USA
www.lifelinefirstaid.com | Send Inquiry | Phone: +1-(877)-3778243
FDA Registration: 3002714597
Products: Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), First Aid Kits, Emergency First Aid Kit (FDA Code: LRR), Hot/Cold Water Bottle (FDA Code: FPF), Disposable Hot/Cold Pack (FDA Code: IMD), ...
Lifeline First Aid LLC provides first aid kits, road kits, accessories, survival kits, water proof kits, bottles & kits, disaster kits and products for breast cancer awareness. Our first aid kits incl more...
www.lifelinefirstaid.com | Send Inquiry | Phone: +1-(877)-3778243
FDA Registration: 3002714597
Products: Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), First Aid Kits, Emergency First Aid Kit (FDA Code: LRR), Hot/Cold Water Bottle (FDA Code: FPF), Disposable Hot/Cold Pack (FDA Code: IMD), ...
Lifeline First Aid LLC provides first aid kits, road kits, accessories, survival kits, water proof kits, bottles & kits, disaster kits and products for breast cancer awareness. Our first aid kits incl more...
Aesculap Implant Systems, Inc. | Address: #3773, Corporate Parkway, Center Valley, Pennsylvania 18034, USA
www.aesculapimplantsystems.com | Send Inquiry | Phone: +1-(610)-984-9081, 800-234-9179
FDA Registration: 3005739625
Products: Small Depth Gauge (FDA Code: HTJ), Flexible Depth Gauge (FDA Code: HTJ), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), ...
Aesculap Implant Systems, Inc. offers a complete line of implant systems and instrumentation for the spine & orthopedic markets. Our orthopedic products include OrthoPilot® navigation system, Colu more...
www.aesculapimplantsystems.com | Send Inquiry | Phone: +1-(610)-984-9081, 800-234-9179
FDA Registration: 3005739625
Products: Small Depth Gauge (FDA Code: HTJ), Flexible Depth Gauge (FDA Code: HTJ), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), ...
Aesculap Implant Systems, Inc. offers a complete line of implant systems and instrumentation for the spine & orthopedic markets. Our orthopedic products include OrthoPilot® navigation system, Colu more...
Unique Technologies, Inc. | Address: 111 Chestnut St., Mohnton, Pennsylvania 19540, USA
www.unique-tech-inc.com | Phone: +1-(610)-775-9191
FDA Registration: 2531324
Products: Microsurgical Knives, Implant Knives, Slit Knives, Cataract Blade, Clear Corneal Knives, Myringotomy Blades & Knives, ...
Unique Technologies, Inc. manufactures and distributes an array of precision micro-surgical cutting instruments. Our UniqueEdge® offers a range of designs that are perfectly suited to the needs of more...
www.unique-tech-inc.com | Phone: +1-(610)-775-9191
FDA Registration: 2531324
Products: Microsurgical Knives, Implant Knives, Slit Knives, Cataract Blade, Clear Corneal Knives, Myringotomy Blades & Knives, ...
Unique Technologies, Inc. manufactures and distributes an array of precision micro-surgical cutting instruments. Our UniqueEdge® offers a range of designs that are perfectly suited to the needs of more...
Xodus Medical, Inc. | Address: Westmoreland Business & Research Park, 702 Prominence Drive, New Kensington, Pennsylvania 15068, USA
www.xodusmedical.com | Send Inquiry | Phone: +1-(724)-337-5500, 800-963-8776
FDA Registration: 2530138 Year Established: 1994 Annual Revenues: USD 1-5 Million Employee Count: ~40 Quality: ISO 9000, CE Certified
Products: Face Masks, Bowls & Basins, Foam Block Needle Counters, Cautery Tip Cleaner, Bulb Irrigation Syringe, Electrosurgical Tip Cleaner, ...
Xodus Medical, Inc. specializes in offering medical safety products. We offer a wide range of products including surgical EZ kits™, safety products, custom medication labels, electrosurgical, pa more...
www.xodusmedical.com | Send Inquiry | Phone: +1-(724)-337-5500, 800-963-8776
FDA Registration: 2530138 Year Established: 1994 Annual Revenues: USD 1-5 Million Employee Count: ~40 Quality: ISO 9000, CE Certified
Products: Face Masks, Bowls & Basins, Foam Block Needle Counters, Cautery Tip Cleaner, Bulb Irrigation Syringe, Electrosurgical Tip Cleaner, ...
Xodus Medical, Inc. specializes in offering medical safety products. We offer a wide range of products including surgical EZ kits™, safety products, custom medication labels, electrosurgical, pa more...
Curette Blade, Inc | Address: 20 Cedar Blvd Suite 410, Pittsburgh, Pennsylvania 15228, USA
www.curetteblade.com | Send Inquiry | Phone: +1-(412)-563-4121
Year Established: 2000 Annual Revenues: < USD 1 Million
Products: Curettes, Surgical Handles, Bone Curettes, Long Handle Curettes, Micro Axial Curettes, Thoracic Curettes, ...
Curette Blade, Inc specializes in curette blades. Our single use curette blade is an alternative for physicians seeking an instrument that offers the convenience of a disposable curette with the stren more...
www.curetteblade.com | Send Inquiry | Phone: +1-(412)-563-4121
Year Established: 2000 Annual Revenues: < USD 1 Million
Products: Curettes, Surgical Handles, Bone Curettes, Long Handle Curettes, Micro Axial Curettes, Thoracic Curettes, ...
Curette Blade, Inc specializes in curette blades. Our single use curette blade is an alternative for physicians seeking an instrument that offers the convenience of a disposable curette with the stren more...
Swissortho Llc | Address: 18 Imperial Place, Suite 1g, Providence, Rhode Island 02903, USA
Phone: +1-(866)-8150604
FDA Registration: 3007887711
Products: Surgical Retractor Systems (FDA Code: GAD), Surgical Retractor (FDA Code: GAD), Scalpel Blade (FDA Code: GES), Patient Position Support (FDA Code: CCX), ...
Swissortho Llc focuses on patient position supports, scalpel blades, surgical retractors and surgical retractor systems. more...
Phone: +1-(866)-8150604
FDA Registration: 3007887711
Products: Surgical Retractor Systems (FDA Code: GAD), Surgical Retractor (FDA Code: GAD), Scalpel Blade (FDA Code: GES), Patient Position Support (FDA Code: CCX), ...
Swissortho Llc focuses on patient position supports, scalpel blades, surgical retractors and surgical retractor systems. more...
Hemostatix Medical Technologies, LLC | Address: 8400 Wolf Lake Dr., Ste. 109, Bartlett, Tennessee 38133, USA
www.hemostatix.com | Send Inquiry | Phone: +1-(901)-261-0012, 800-722-5735
FDA Registration: 3006119098
Products: Scalpels, Scalpel Handle (FDA Code: GDZ), Scalpel Blade (FDA Code: GES), Electrosurgical Cutting and Coagulation Device (FDA Code: GEI), ...
Hemostatix Medical Technologies, LLC offers hemostatix thermal scalpel system. Our hemostatix thermal scalpel system offers exact temperature control ranging from 70° to 300° C at the push of a button more...
www.hemostatix.com | Send Inquiry | Phone: +1-(901)-261-0012, 800-722-5735
FDA Registration: 3006119098
Products: Scalpels, Scalpel Handle (FDA Code: GDZ), Scalpel Blade (FDA Code: GES), Electrosurgical Cutting and Coagulation Device (FDA Code: GEI), ...
Hemostatix Medical Technologies, LLC offers hemostatix thermal scalpel system. Our hemostatix thermal scalpel system offers exact temperature control ranging from 70° to 300° C at the push of a button more...
Medworks | Address: 707 Meadowview Drive, Johnson City, Tennessee 37604, USA
www.medexamtools.com | Send Inquiry | Phone: +1-(423)-926-3244, 800-323-9790
Year Established: 1971 Annual Revenues: < USD 1 Million
Products: Stethoscopes, Blood Pressure Monitors, Clinical Mercury Thermometers (FDA Code: FLK), Operating Scissors, Neuromuscular Stimulator, Scalpel Blade (FDA Code: GES), ...
Medworks offers stethoscopes, surgicals, blood pressure monitors, percussion hammers, tuning forks, calipers, meters, thermometers, goniometers, and replacement parts. Our rectal thermometers are 4.5& more...
www.medexamtools.com | Send Inquiry | Phone: +1-(423)-926-3244, 800-323-9790
Year Established: 1971 Annual Revenues: < USD 1 Million
Products: Stethoscopes, Blood Pressure Monitors, Clinical Mercury Thermometers (FDA Code: FLK), Operating Scissors, Neuromuscular Stimulator, Scalpel Blade (FDA Code: GES), ...
Medworks offers stethoscopes, surgicals, blood pressure monitors, percussion hammers, tuning forks, calipers, meters, thermometers, goniometers, and replacement parts. Our rectal thermometers are 4.5& more...
Banyan International Corp | Address: P.O. Box 1779, Abilene, Texas 79604-1779, USA
www.statkit.com | Send Inquiry | Phone: +1-(325)-677-1874
Year Established: 1972 Annual Revenues: USD 5-10 Million Employee Count: ~20
Products: Endotracheal Tubes, Anesthetics, Antihistamines, Cardiovasculars, Cardiovasculars, Chemical Supplies, ...
Banyan International Corp specializes in emergency medical kits. We provide life-saving emergency equipment to physicians & dentists in a compact, organized and easy-to-use format. Our Stat Kit® 9 more...
www.statkit.com | Send Inquiry | Phone: +1-(325)-677-1874
Year Established: 1972 Annual Revenues: USD 5-10 Million Employee Count: ~20
Products: Endotracheal Tubes, Anesthetics, Antihistamines, Cardiovasculars, Cardiovasculars, Chemical Supplies, ...
Banyan International Corp specializes in emergency medical kits. We provide life-saving emergency equipment to physicians & dentists in a compact, organized and easy-to-use format. Our Stat Kit® 9 more...
Argon Medical Devices Inc. | Address: 1445 Flat Creek Road, Athens, Texas 75751, USA
www.argonmedical.com | Send Inquiry | Phone: +1-(903)-675-9321, 800-927-4669
FDA Registration: 1625425
Products: Irrigation Sets & Tubing, General Medical Supplies, General Surgical Instruments, General Surgery Supplies, Syringe/Needle Combos, Guide Wire Accessories, ...
Argon Medical Devices Inc. manufactures and supplies single-use vascular access devices. Our products are divided into cardiology, radiology and critical care product lines. Our products include arter more...
www.argonmedical.com | Send Inquiry | Phone: +1-(903)-675-9321, 800-927-4669
FDA Registration: 1625425
Products: Irrigation Sets & Tubing, General Medical Supplies, General Surgical Instruments, General Surgery Supplies, Syringe/Needle Combos, Guide Wire Accessories, ...
Argon Medical Devices Inc. manufactures and supplies single-use vascular access devices. Our products are divided into cardiology, radiology and critical care product lines. Our products include arter more...
Wexler Surgical | Address: 11333 Chimney Rock Road, Suite #120, Houston, Texas 77035, USA
www.wexlersurgical.com | Send Inquiry | Phone: +1-(713)-723-6900, 800-414-1076
FDA Registration: 1646747 Year Established: 1998 Annual Revenues: USD 1-5 Million Employee Count: ~10 Quality: CE Certified
Products: Bone Rasps (FDA Code: HTR), Bone Clamp (FDA Code: HXD), Blood Collection Sets with Needle Holder, Blood Needle Holder Systems, Calipers (FDA Code: KTZ), Cannula Clamp (FDA Code: FKC), ...
Wexler Surgical offers the specialty surgical instrumentation in titanium and stainless steel for ophthalmic surgery. Our wide range of products include forceps, needle holders, scissors, retractors, more...
www.wexlersurgical.com | Send Inquiry | Phone: +1-(713)-723-6900, 800-414-1076
FDA Registration: 1646747 Year Established: 1998 Annual Revenues: USD 1-5 Million Employee Count: ~10 Quality: CE Certified
Products: Bone Rasps (FDA Code: HTR), Bone Clamp (FDA Code: HXD), Blood Collection Sets with Needle Holder, Blood Needle Holder Systems, Calipers (FDA Code: KTZ), Cannula Clamp (FDA Code: FKC), ...
Wexler Surgical offers the specialty surgical instrumentation in titanium and stainless steel for ophthalmic surgery. Our wide range of products include forceps, needle holders, scissors, retractors, more...
C&a Scientific Co. | Address: 7241 Gabe Court, Manassas, Virginia 20109-2434, USA
www.cnascientific.com | Send Inquiry | Phone: +001-(703)-330-1413
FDA Registration: 1122839 Year Established: 1990 Annual Revenues: USD 1-5 Million Quality: ISO 9001, ISO 9002 Certified
Products: Blood Collect Tubes, Microscopes, General Medical Supplies, General Surgery Supplies, Pipettors, Pipettes, Light Sources Microscope Light Source, ...
C&a Scientific Co. produces blood collect tubes, microscopes, pipettors, pipettes, light sources, microscope light source, operating microscope filters, fixed filters, operating microscope filters, tw more...
www.cnascientific.com | Send Inquiry | Phone: +001-(703)-330-1413
FDA Registration: 1122839 Year Established: 1990 Annual Revenues: USD 1-5 Million Quality: ISO 9001, ISO 9002 Certified
Products: Blood Collect Tubes, Microscopes, General Medical Supplies, General Surgery Supplies, Pipettors, Pipettes, Light Sources Microscope Light Source, ...
C&a Scientific Co. produces blood collect tubes, microscopes, pipettors, pipettes, light sources, microscope light source, operating microscope filters, fixed filters, operating microscope filters, tw more...
Personna American Safety Razor Company | Address: One Razor Blade Lane, Verona, Virginia 24482-0979, USA
www.asrco.com | Send Inquiry | Phone: +1-(540)-248-8000
FDA Registration: 1119522 Year Established: 1875 Annual Revenues: USD 100-500 Million Employee Count: ~450 Quality: ISO 9001, CE Certified
Products: Surgical Blades, Surgical Handles, General Medical Supplies, Nail Nippers & Trimmers, Razors, Razors & Blades, ...
Personna American Safety Razor Company is a worldwide blade manufacturer. We make surgical blades & handles & introduce sterile stainless steel surgical blades. Our Low Profile 0.010 inch microtome bl more...
www.asrco.com | Send Inquiry | Phone: +1-(540)-248-8000
FDA Registration: 1119522 Year Established: 1875 Annual Revenues: USD 100-500 Million Employee Count: ~450 Quality: ISO 9001, CE Certified
Products: Surgical Blades, Surgical Handles, General Medical Supplies, Nail Nippers & Trimmers, Razors, Razors & Blades, ...
Personna American Safety Razor Company is a worldwide blade manufacturer. We make surgical blades & handles & introduce sterile stainless steel surgical blades. Our Low Profile 0.010 inch microtome bl more...
AOA Orthodontic Appliances | Address: 13931 Spring St., P.O. Box 725, Sturtevant, Wisconsin 53177, USA
www.aoalab.com | Phone: +1-(800)-262-5221
FDA Registration: 2184045
Products: Orthodontic Anchor System, Scalpel Blade (FDA Code: GES), Diagnostic/Surgical Loupe (FDA Code: FSP), Medical Device, Sterilant (FDA Code: MED), Medical Devices, Disinfectant (FDA Code: LRJ), Protective Barrier Cover (FDA Code: MMP), ...
AOA Orthodontic Appliances is a provider of orthodontic appliances. Our product line includes active vertical correctors, arch development appliances, functional appliances, positioners and setups and more...
www.aoalab.com | Phone: +1-(800)-262-5221
FDA Registration: 2184045
Products: Orthodontic Anchor System, Scalpel Blade (FDA Code: GES), Diagnostic/Surgical Loupe (FDA Code: FSP), Medical Device, Sterilant (FDA Code: MED), Medical Devices, Disinfectant (FDA Code: LRJ), Protective Barrier Cover (FDA Code: MMP), ...
AOA Orthodontic Appliances is a provider of orthodontic appliances. Our product line includes active vertical correctors, arch development appliances, functional appliances, positioners and setups and more...
Shoney Scientific, Inc. | Address: West 223 North 720 Saratoga Drive, Suite 120, Waukesha, Wisconsin 53186, USA
www.shoney.com | Send Inquiry | Phone: +1-(262)-970-0170
FDA Registration: 2183650 Year Established: 1986 Annual Revenues: < USD 1 Million
Products: Adhesive Bandages (FDA Code: KGX), Child Ear Curette, Angular Ear Curette, Buck Ear Curettes, Connecting Flexible Aspirating Tube (FDA Code: BYY), Cast Bandage (FDA Code: ITG), ...
Shoney Scientific, Inc. is an OEM medical device manufacturing company. We offer a complete range of custom production services, from prototype development to manufacturing, packaging and sterilizatio more...
www.shoney.com | Send Inquiry | Phone: +1-(262)-970-0170
FDA Registration: 2183650 Year Established: 1986 Annual Revenues: < USD 1 Million
Products: Adhesive Bandages (FDA Code: KGX), Child Ear Curette, Angular Ear Curette, Buck Ear Curettes, Connecting Flexible Aspirating Tube (FDA Code: BYY), Cast Bandage (FDA Code: ITG), ...
Shoney Scientific, Inc. is an OEM medical device manufacturing company. We offer a complete range of custom production services, from prototype development to manufacturing, packaging and sterilizatio more...
Hospital & Homecare Imp. & Exp. Co., Ltd. | Address: Room 608-611, No.5 Zhongtai Int. Plaza, No.311 Middle of Jiangdong Rd, Central Business Dist, Nanjing, Jiangsu, China 
www.aline-medical.com | Send Inquiry | Phone: +86-(25)-84573232
FDA Registration: 3006897996
Products: Adhesive Bandages (FDA Code: KGX), Adult Tongue Depressor (FDA Code: FMA), Cardiovascular Biopsy Needle (FDA Code: DWO), Adhesive Tape Solvent (FDA Code: KOX), Aerosol Adhesive Drape (FDA Code: KGT), Cast Bandage (FDA Code: ITG), ...
Hospital & Homecare Imp. & Exp. Co., Ltd. is mainly engaged in medical product development, covering thousands of products within the medical field. We provide Surgical & Optical Instruments, Laborato more...
www.aline-medical.com | Send Inquiry | Phone: +86-(25)-84573232
FDA Registration: 3006897996
Products: Adhesive Bandages (FDA Code: KGX), Adult Tongue Depressor (FDA Code: FMA), Cardiovascular Biopsy Needle (FDA Code: DWO), Adhesive Tape Solvent (FDA Code: KOX), Aerosol Adhesive Drape (FDA Code: KGT), Cast Bandage (FDA Code: ITG), ...
Hospital & Homecare Imp. & Exp. Co., Ltd. is mainly engaged in medical product development, covering thousands of products within the medical field. We provide Surgical & Optical Instruments, Laborato more...
Pentafarma | Address: Apartado Postal N. 69.229, Caracas, Miranda, Venezuela
Phone: 583-644-5427
Products: Dissecting Scalpel Blades, Single Handed Scalpel Blade Remover, Scalpel Blade (FDA Code: GES), Single Lumen Hypodermic Needle (FDA Code: FMI), ...
Pentafarma supplies needle, hypodermic and single lumen. more...
Phone: 583-644-5427
Products: Dissecting Scalpel Blades, Single Handed Scalpel Blade Remover, Scalpel Blade (FDA Code: GES), Single Lumen Hypodermic Needle (FDA Code: FMI), ...
Pentafarma supplies needle, hypodermic and single lumen. more...
Gowllands Limited | Address: 196 Morland Road, Croydon CR9 6BN, United Kingdom 
Phone: +44-(20)-8654-3011
Annual Revenues: USD 1-5 Million
Products: Direct Ophthalmoscopes, Indirect Ophthalmoscopes, Spectacle Indirect Ophthalmoscope, Binocular Indirect Ophthalmoscopes, Laser Indirect Ophthalmoscope, Monocular Indirect Ophthalmoscope, ...
Gowllands Limited deals with medical equipment. more...
Phone: +44-(20)-8654-3011
Annual Revenues: USD 1-5 Million
Products: Direct Ophthalmoscopes, Indirect Ophthalmoscopes, Spectacle Indirect Ophthalmoscope, Binocular Indirect Ophthalmoscopes, Laser Indirect Ophthalmoscope, Monocular Indirect Ophthalmoscope, ...
Gowllands Limited deals with medical equipment. more...
Gowllands Medical Devices Limited | Address: 29 Neville Road, Croydon CR0 2DS, United Kingdom
www.gowllandsmed.com | Send Inquiry | Phone: +44-(20)-8683-1221
FDA Registration: 9610791
Products: Infant Tongue Depressor (FDA Code: FMA), Adult Tongue Depressor (FDA Code: FMA), Ear Speculum (FDA Code: EPY), Diagnostic/Surgical Loupe (FDA Code: FSP), Battery-Operated Operating Headlamp (FDA Code: HPP), Battery-Powered Ophthalmoscope (FDA Code: HLJ), ...
Gowllands Medical Devices Limited manufactures and exports diagnostic instruments. Our surgical instruments include diagnostics, anesthesia & vaccination instruments, scalpels, scissors, TC forceps, f more...
www.gowllandsmed.com | Send Inquiry | Phone: +44-(20)-8683-1221
FDA Registration: 9610791
Products: Infant Tongue Depressor (FDA Code: FMA), Adult Tongue Depressor (FDA Code: FMA), Ear Speculum (FDA Code: EPY), Diagnostic/Surgical Loupe (FDA Code: FSP), Battery-Operated Operating Headlamp (FDA Code: HPP), Battery-Powered Ophthalmoscope (FDA Code: HLJ), ...
Gowllands Medical Devices Limited manufactures and exports diagnostic instruments. Our surgical instruments include diagnostics, anesthesia & vaccination instruments, scalpels, scissors, TC forceps, f 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.
