Disposable Surgical Instrument Kit Suppliers
Limit companies to: Worldwide USA
SIM Surgical | Address: 1650 Headland Drive, St. Louis, Missouri 63026, USA 
www.simsurgical.com | Send Inquiry | Phone: +1-(800)-521-2985
FDA Registration: 1935627 Year Established: 2001 Annual Revenues: < USD 1 Million Employee Count: ~40 Quality: ISO 13485 Certified
Products: Common Surgical Instrument, Packaging, Repair Service for Medical Instruments, Thread Whirled Monoaxial Screws, Thread Whirled Polyaxial Screws, Titanium Interbody Devices, ...
SIM Surgical is a contract manufacturer of surgical instruments. Our product portfolio comprises of implants and instruments. more...
www.simsurgical.com | Send Inquiry | Phone: +1-(800)-521-2985
FDA Registration: 1935627 Year Established: 2001 Annual Revenues: < USD 1 Million Employee Count: ~40 Quality: ISO 13485 Certified
Products: Common Surgical Instrument, Packaging, Repair Service for Medical Instruments, Thread Whirled Monoaxial Screws, Thread Whirled Polyaxial Screws, Titanium Interbody Devices, ...
SIM Surgical is a contract manufacturer of surgical instruments. Our product portfolio comprises of implants and instruments. more...
Windstone Medical Packaging, Inc. | Address: 1602 4th Ave. N., Billings, Montana 59101-1521, USA
www.windstonemedical.com | Send Inquiry | Phone: +1-(406)-259-6387, 800-637-7056
FDA Registration: 3025168 Year Established: 1978 Annual Revenues: USD 5-10 Million Employee Count: ~40 Quality: ISO 9002 Certified
Products: Biopsy Trays, Angiographic Injector and Syringe (FDA Code: DXT), Contract Packaging, Contract Sterilization, Custom/Special Procedure Pack, Custom/Special Procedure Tray, ...
Windstone Medical Packaging, Inc. offers custom procedure trays, diagnostic procedure trays, non-sterile kits, foam positioning products, contract packaging and sterilization products. Our diagnostic more...
www.windstonemedical.com | Send Inquiry | Phone: +1-(406)-259-6387, 800-637-7056
FDA Registration: 3025168 Year Established: 1978 Annual Revenues: USD 5-10 Million Employee Count: ~40 Quality: ISO 9002 Certified
Products: Biopsy Trays, Angiographic Injector and Syringe (FDA Code: DXT), Contract Packaging, Contract Sterilization, Custom/Special Procedure Pack, Custom/Special Procedure Tray, ...
Windstone Medical Packaging, Inc. offers custom procedure trays, diagnostic procedure trays, non-sterile kits, foam positioning products, contract packaging and sterilization products. Our diagnostic more...
Universal Medical Products, Inc. | Address: 1550 N. 20th Circle, Lincoln, Nebraska 68503, USA
www.u-m-p.com | Phone: +1-(800)-206-1045
Year Established: 1997 Annual Revenues: USD 1-5 Million Employee Count: ~20
Products: Patient Monitoring Devices, Bed Patient Monitor (FDA Code: KMI), Pull String Monitors, Infrared Monitors, Wireless Systems, Bed Sentry Monitors, ...
Universal Medical Products, Inc. develops, manufactures and markets restraint-free products. Our product list comprises of bed monitors, chair monitors, sentry bed & chair pads monitors, pull string m more...
www.u-m-p.com | Phone: +1-(800)-206-1045
Year Established: 1997 Annual Revenues: USD 1-5 Million Employee Count: ~20
Products: Patient Monitoring Devices, Bed Patient Monitor (FDA Code: KMI), Pull String Monitors, Infrared Monitors, Wireless Systems, Bed Sentry Monitors, ...
Universal Medical Products, Inc. develops, manufactures and markets restraint-free products. Our product list comprises of bed monitors, chair monitors, sentry bed & chair pads monitors, pull string m more...
Pak Manufacturing Inc. | Address: 704 South 21st Street, Irvington, New Jersey 07111, USA
www.pakmanufacturing.com | Send Inquiry | Phone: +1-(973)-372-1090
Products: Curettes, General Surgical Instruments, Bone Holding Clamps, Bone Clamp (FDA Code: HXD), Disposable Surgical Instrument Kit (FDA Code: KDD), Bone Skid (FDA Code: HWO), ...
Pak Manufacturing Inc. specializes in the production of forged surgical instruments. We also provide custom configurations built from raw forgings. We also focus on machined instruments & components, more...
www.pakmanufacturing.com | Send Inquiry | Phone: +1-(973)-372-1090
Products: Curettes, General Surgical Instruments, Bone Holding Clamps, Bone Clamp (FDA Code: HXD), Disposable Surgical Instrument Kit (FDA Code: KDD), Bone Skid (FDA Code: HWO), ...
Pak Manufacturing Inc. specializes in the production of forged surgical instruments. We also provide custom configurations built from raw forgings. We also focus on machined instruments & components, more...
Derma Sciences, Inc. | Address: 214 Carnegie Center Suite 300, Princeton, New Jersey 08540, USA
www.dermasciences.com | Send Inquiry | Phone: +1-(609)-514.4744
FDA Registration: 9680091 Year Established: 1991 Annual Revenues: USD 5-10 Million Employee Count: ~20
Products: Gauze, Gauze Dressings, Packings, Self-Adherent Wraps/Bandages, Tubular Gauzes, Ulcer, Burn & Wound Dressings, ...
Derma Sciences, Inc. manufactures & markets a complete line of products for wound and skin care. Our products can be broken down into five categories including advanced wound care, traditional wound c more...
www.dermasciences.com | Send Inquiry | Phone: +1-(609)-514.4744
FDA Registration: 9680091 Year Established: 1991 Annual Revenues: USD 5-10 Million Employee Count: ~20
Products: Gauze, Gauze Dressings, Packings, Self-Adherent Wraps/Bandages, Tubular Gauzes, Ulcer, Burn & Wound Dressings, ...
Derma Sciences, Inc. manufactures & markets a complete line of products for wound and skin care. Our products can be broken down into five categories including advanced wound care, traditional wound c more...
Ethox International, Inc. | Address: 251 Seneca Street, Buffalo, New York 14204-2088, USA
www.ethoxcorp.com | Send Inquiry | Phone: +1-(716)-842.4000, 800.521.1022
FDA Registration: 1314417 Year Established: 1966 Annual Revenues: USD 10-25 Million
Products: CPR Equipment, General EMT, General Medical Supplies, General Urology Supplies, General Surgical Aids, General Surgery Supplies, ...
Ethox International, Inc. provides the medical device and pharmaceutical industries integrated OEM design and manufacturing, sterilization, toxicology, analytical chemistry, and microbiology. We also more...
www.ethoxcorp.com | Send Inquiry | Phone: +1-(716)-842.4000, 800.521.1022
FDA Registration: 1314417 Year Established: 1966 Annual Revenues: USD 10-25 Million
Products: CPR Equipment, General EMT, General Medical Supplies, General Urology Supplies, General Surgical Aids, General Surgery Supplies, ...
Ethox International, Inc. provides the medical device and pharmaceutical industries integrated OEM design and manufacturing, sterilization, toxicology, analytical chemistry, and microbiology. We also more...
New England Medical Corp. | Address: 2274 Albany Post Rd., Walden, New York 12586, USA
Phone: +1-(845)-778-4200
Products: Electrode Cables (FDA Code: IKD), Gas Cylinder Pressure Regulator (FDA Code: CAN), Electrosurgical Cutting and Coagulation Device (FDA Code: GEI), Disposable Surgical Instrument Kit (FDA Code: KDD), Gynecologic Electrocautery and Accessories (FDA Code: HGI), Manual Gastro-Urology Surgical Instrument (FDA Code: KOA), ...
New England Medical Corp deals with surgical instruments. Our products include electrosurgical accessories, disposable surgical instruments, gas cylinder pressure regulators, pressure infusor for IV b more...
Phone: +1-(845)-778-4200
Products: Electrode Cables (FDA Code: IKD), Gas Cylinder Pressure Regulator (FDA Code: CAN), Electrosurgical Cutting and Coagulation Device (FDA Code: GEI), Disposable Surgical Instrument Kit (FDA Code: KDD), Gynecologic Electrocautery and Accessories (FDA Code: HGI), Manual Gastro-Urology Surgical Instrument (FDA Code: KOA), ...
New England Medical Corp deals with surgical instruments. Our products include electrosurgical accessories, disposable surgical instruments, gas cylinder pressure regulators, pressure infusor for IV b more...
Sterigenics Us Llc | Address: 10811 Withers Cove Park Drive, Charlotte, North Carolina 28278, USA
www.sterigenics.com/usa.htm | Send Inquiry | Phone: +1-(630)-928-1787
FDA Registration: 1058584
Products: Elastic Bandages (FDA Code: FQM), Laboratory Testing Services, Disposable Surgical Instrument Kit (FDA Code: KDD), Contract Sterilization, Contract Sterilization Services, Pharmaceutical Sterilization, ...
Sterigenics Us Llc provides contract sterilization solutions to the medical device and pharmaceutical industries, using ethylene oxide, gamma and electron beam irradiation. Our labs offer a comprehens more...
www.sterigenics.com/usa.htm | Send Inquiry | Phone: +1-(630)-928-1787
FDA Registration: 1058584
Products: Elastic Bandages (FDA Code: FQM), Laboratory Testing Services, Disposable Surgical Instrument Kit (FDA Code: KDD), Contract Sterilization, Contract Sterilization Services, Pharmaceutical Sterilization, ...
Sterigenics Us Llc provides contract sterilization solutions to the medical device and pharmaceutical industries, using ethylene oxide, gamma and electron beam irradiation. Our labs offer a comprehens more...
Closure Medical | Address: 5250 Greens Dairy Rd., Raleigh, North Carolina 27616, USA
Phone: +1-(919)-876-7800, 888-257-7633
Annual Revenues: USD 10-25 Million Employee Count: ~80 Quality: ISO 9001, CE Certified
Products: Suture Free Wound Closure Adhesives, Wound Closure Adhesive (FDA Code: MGO), Vascular Device for Promoting Embolization (FDA Code: KRD), Topical Approximation of Skin Tissue Adhesive (FDA Code: MPN), Waterproof Adhesive Strip, Ophthalmology Tissue Adhesive (FDA Code: LZQ), ...
Closure Medical are providers of nexacryl and n-butyl cyanoacrylate for treatment of corneal ulcerations. Dermabond is a topical skin adhesive. Nexaband family n-butyl cyanacrylate and 2-octyl cyanoac more...
Phone: +1-(919)-876-7800, 888-257-7633
Annual Revenues: USD 10-25 Million Employee Count: ~80 Quality: ISO 9001, CE Certified
Products: Suture Free Wound Closure Adhesives, Wound Closure Adhesive (FDA Code: MGO), Vascular Device for Promoting Embolization (FDA Code: KRD), Topical Approximation of Skin Tissue Adhesive (FDA Code: MPN), Waterproof Adhesive Strip, Ophthalmology Tissue Adhesive (FDA Code: LZQ), ...
Closure Medical are providers of nexacryl and n-butyl cyanoacrylate for treatment of corneal ulcerations. Dermabond is a topical skin adhesive. Nexaband family n-butyl cyanacrylate and 2-octyl cyanoac more...
Haywood Vocational Opportunities | Address: 172 Riverbend Street, Waynesville, North Carolina 28786, USA
www.hvoinc.com | Phone: +1-(828)-456-4455
FDA Registration: 1043549 Annual Revenues: USD 10-25 Million Quality: ISO 9001 Certified
Products: Surgical Drapes & Packs (FDA Code: KKX), Surgical Drapes (FDA Code: KKX), Sterile Surgical Drapes (FDA Code: KKX), Fluid Collection Pouches, Disposable Surgical Drape (FDA Code: KKX), Ophthalmic Patient Drape (FDA Code: HMT), ...
Haywood Vocational Opportunities specializes in disposable health care products, custom surgical drapes, custom fluid pouches, table covers, and instrument covers. more...
www.hvoinc.com | Phone: +1-(828)-456-4455
FDA Registration: 1043549 Annual Revenues: USD 10-25 Million Quality: ISO 9001 Certified
Products: Surgical Drapes & Packs (FDA Code: KKX), Surgical Drapes (FDA Code: KKX), Sterile Surgical Drapes (FDA Code: KKX), Fluid Collection Pouches, Disposable Surgical Drape (FDA Code: KKX), Ophthalmic Patient Drape (FDA Code: HMT), ...
Haywood Vocational Opportunities specializes in disposable health care products, custom surgical drapes, custom fluid pouches, table covers, and instrument covers. 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...
Washington-Greene County Branch Pennsylvania Assoc | Address: 566, East Maiden Street, Washington, Pennsylvania 15301, USA
Phone: +1-(724)-228-0770
FDA Registration: 2521990
Products: Suture Removal Kit (FDA Code: MCZ), Disposable Surgical Instrument Kit (FDA Code: KDD), General Surgery Tray (FDA Code: LRO), Tracheotomy Care Kit (FDA Code: NXA), ...
Washington-Greene County Branch Pennsylvania Assoc offers tracheotomy care kits. more...
Phone: +1-(724)-228-0770
FDA Registration: 2521990
Products: Suture Removal Kit (FDA Code: MCZ), Disposable Surgical Instrument Kit (FDA Code: KDD), General Surgery Tray (FDA Code: LRO), Tracheotomy Care Kit (FDA Code: NXA), ...
Washington-Greene County Branch Pennsylvania Assoc offers tracheotomy care kits. more...
Kentron Health Care, Inc. | Address: 3604 Kelton Jackson Rd., Springfield, Tennessee 37172, USA
www.kentronmedical.com | Send Inquiry | Phone: +1-(866)-385-0573
FDA Registration: 1062671
Products: Cardiology Stethoscope, Blood Glucose Test Strips, Aneroid Sphygmomanometer, Cold & Hot Packs, Blood Glucose Monitor Kit, Body Bag, Cadaver, ...
Kentron Health Care, Inc. is a manufacturer of surgical and medical instruments. Our product line includes sterile and non sterile latex gloves, vinyl & polyethylene gloves, hospital plastics, nursing more...
www.kentronmedical.com | Send Inquiry | Phone: +1-(866)-385-0573
FDA Registration: 1062671
Products: Cardiology Stethoscope, Blood Glucose Test Strips, Aneroid Sphygmomanometer, Cold & Hot Packs, Blood Glucose Monitor Kit, Body Bag, Cadaver, ...
Kentron Health Care, Inc. is a manufacturer of surgical and medical instruments. Our product line includes sterile and non sterile latex gloves, vinyl & polyethylene gloves, hospital plastics, nursing more...
Arthrocare Corporation | Address: 7500 Rialto Boulevard, Building Two, Suite 100, Austin, Texas 78735, USA
www.arthrocare.com | Send Inquiry | Phone: +1-(512)-391-3900
FDA Registration: 3012358417 Year Established: 1993 Annual Revenues: < USD 1 Million Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Vertebroplasty, Bone Cement (FDA Code: LOD), Ear & Hearing Protection, Goggles & Protective Eyewear, Calcium Phosphate Bone Cements, Bioreabsorbable Bone Cement, ...
Arthrocare Corporation designs surgical instruments that improve patient outcomes by using our internationally patented Coblation® technology. Our technology precisely dissolves target tissue and more...
www.arthrocare.com | Send Inquiry | Phone: +1-(512)-391-3900
FDA Registration: 3012358417 Year Established: 1993 Annual Revenues: < USD 1 Million Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Vertebroplasty, Bone Cement (FDA Code: LOD), Ear & Hearing Protection, Goggles & Protective Eyewear, Calcium Phosphate Bone Cements, Bioreabsorbable Bone Cement, ...
Arthrocare Corporation designs surgical instruments that improve patient outcomes by using our internationally patented Coblation® technology. Our technology precisely dissolves target tissue and more...
Hallmark Sales Corporation | Address: 1601 Peachleaf, Houston, Texas 77039, USA
Phone: +1-(281)-590-1367
Year Established: 1978 Annual Revenues: USD 1-5 Million Employee Count: ~80
Products: First Aid Kit Boxes, OSHA Compliant, First Aid Kits, First Aid Kits, Weatherproof First Aid Kit, Travel First Aid Kit with Drug (FDA Code: LRR), Emergency First Aid Kit (FDA Code: LRR), ...
Hallmark Sales Corporation deals with first aid kits. more...
Phone: +1-(281)-590-1367
Year Established: 1978 Annual Revenues: USD 1-5 Million Employee Count: ~80
Products: First Aid Kit Boxes, OSHA Compliant, First Aid Kits, First Aid Kits, Weatherproof First Aid Kit, Travel First Aid Kit with Drug (FDA Code: LRR), Emergency First Aid Kit (FDA Code: LRR), ...
Hallmark Sales Corporation deals with first aid kits. more...
US Medco, Inc. | Address: 2900 Wilcrest Dr. Suite 163, Houston, Texas 77042, USA
www.usmedcoinc.com | Send Inquiry | Phone: +1-(713)-7831111
FDA Registration: 3002532929
Products: General Surgical Aids, Adhesive Bandages (FDA Code: KGX), Bandages, Adhesive Tape, Disposable Surgical Instrument Kit (FDA Code: KDD), Cast Bandage (FDA Code: ITG), ...
US Medco, Inc. offers surgical products such as surgical gauze, POP & adhesive bandages, surgical kits for ophthalmic, orthopedic & knee surgery, and adhesive tapes. more...
www.usmedcoinc.com | Send Inquiry | Phone: +1-(713)-7831111
FDA Registration: 3002532929
Products: General Surgical Aids, Adhesive Bandages (FDA Code: KGX), Bandages, Adhesive Tape, Disposable Surgical Instrument Kit (FDA Code: KDD), Cast Bandage (FDA Code: ITG), ...
US Medco, Inc. offers surgical products such as surgical gauze, POP & adhesive bandages, surgical kits for ophthalmic, orthopedic & knee surgery, and adhesive tapes. more...
Ballard Medical Products | Address: 12050 Lone Peak Pkwy., Draper, Utah 84020, USA
Phone: +1-(770)-587-7835
Products: Scrubs, Single-Use Medical Disposables, Disposable Medical Consumables, Disposable Surgical Instrument (FDA Code: KDC), Disposable Surgical Instrument Kit (FDA Code: KDD), ...
Ballard Medical Products is a manufacturer and marketer of specialized medical products. We design, produce and distribute disposable medical items used in critical care & surgical situations. Our Tra more...
Phone: +1-(770)-587-7835
Products: Scrubs, Single-Use Medical Disposables, Disposable Medical Consumables, Disposable Surgical Instrument (FDA Code: KDC), Disposable Surgical Instrument Kit (FDA Code: KDD), ...
Ballard Medical Products is a manufacturer and marketer of specialized medical products. We design, produce and distribute disposable medical items used in critical care & surgical situations. Our Tra more...
Medical Techniques USA | Address: 125 North 400 West, Suite C, North Salt Lake, Utah 84054, USA
www.medicaltechniquesusa.com | Send Inquiry | Phone: +1-(801)-936-4501
FDA Registration: 1721368 Year Established: 1980 Annual Revenues: USD 1-5 Million Quality: ISO 13485, CE Certified
Products: Biopsy Kit, Angiographic Injector and Syringe (FDA Code: DXT), Angioplasty Syringe, Balloon Inflation Syringe (FDA Code: MAV), Cardiac Catheterization Kit (FDA Code: OES), Amniotic Fluid Sampler (FDA Code: HIO), ...
Medical Techniques USA provides cardiology, radiology, angiography, and surgical products. Our products are designed to diagnostic and interventional catheterization needs. We manufacture disposable p more...
www.medicaltechniquesusa.com | Send Inquiry | Phone: +1-(801)-936-4501
FDA Registration: 1721368 Year Established: 1980 Annual Revenues: USD 1-5 Million Quality: ISO 13485, CE Certified
Products: Biopsy Kit, Angiographic Injector and Syringe (FDA Code: DXT), Angioplasty Syringe, Balloon Inflation Syringe (FDA Code: MAV), Cardiac Catheterization Kit (FDA Code: OES), Amniotic Fluid Sampler (FDA Code: HIO), ...
Medical Techniques USA provides cardiology, radiology, angiography, and surgical products. Our products are designed to diagnostic and interventional catheterization needs. We manufacture disposable p more...
Custom Healthcare Systems, Inc. | Address: 4205 Eubank Rd., Richmond, Virginia 23231, USA
Phone: +1-(804)-421-5959
FDA Registration: 1121091 Annual Revenues: USD 1-5 Million Employee Count: ~20
Products: Procedure Trays, Cotton Balls, Dressing Change Tray, IV Start Tray, Sterile Absorbent Tipped Applicator (FDA Code: KXG), Skin Prep Tray (FDA Code: OJU), ...
Custom Healthcare Systems, Inc. offers procedure trays, cotton balls, dressing change trays, skin prep trays, and IV start trays. more...
Phone: +1-(804)-421-5959
FDA Registration: 1121091 Annual Revenues: USD 1-5 Million Employee Count: ~20
Products: Procedure Trays, Cotton Balls, Dressing Change Tray, IV Start Tray, Sterile Absorbent Tipped Applicator (FDA Code: KXG), Skin Prep Tray (FDA Code: OJU), ...
Custom Healthcare Systems, Inc. offers procedure trays, cotton balls, dressing change trays, skin prep trays, and IV start trays. more...
Avid Medical, Inc. | Address: 9000 Westmont Dr., Stonehouse Commerce Park, Toano, Virginia 23168, USA
www.avidmedical.com | Send Inquiry | Phone: +1-(888)-564-7153
FDA Registration: 1047429
Products: Procedure Trays, Trays, Spinal Needles, Custom/Special Procedure Tray, Specialty Needles, Epidural Needles, ...
Avid Medical, Inc. deals with custom procedure trays. Our products include CPTs, Avid standards, anesthesia and procedure+plus. Our anesthesia products include specialty spinal and epidural needles & more...
www.avidmedical.com | Send Inquiry | Phone: +1-(888)-564-7153
FDA Registration: 1047429
Products: Procedure Trays, Trays, Spinal Needles, Custom/Special Procedure Tray, Specialty Needles, Epidural Needles, ...
Avid Medical, Inc. deals with custom procedure trays. Our products include CPTs, Avid standards, anesthesia and procedure+plus. Our anesthesia products include specialty spinal and epidural needles & more...
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FDA Code / Regulation: KDD / 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.
