Ophthalmic Eye Shield Suppliers
Limit companies to: Worldwide USA
Sun Med | Address: 12393 Belcher Road Unit 450, Largo, Florida 33773-3097, USA 
www.sunmedusa.com | Send Inquiry | Phone: +1-(727)-530-7099, 800-433-2797
FDA Registration: 1036445 Annual Revenues: USD 5-10 Million Employee Count: ~20
Products: CPR Equipment, Larynx & Nasopharynx & Rhino, General EMT, Resuscitation, Resuscitation Equipment Kits, Resuscitation Equipment, ...
Sun Med imports and distributes finished medical devices. We are the global supplier of anesthesia, respiratory and urology accessories. We specialize in airway management products. We offer a complet more...
www.sunmedusa.com | Send Inquiry | Phone: +1-(727)-530-7099, 800-433-2797
FDA Registration: 1036445 Annual Revenues: USD 5-10 Million Employee Count: ~20
Products: CPR Equipment, Larynx & Nasopharynx & Rhino, General EMT, Resuscitation, Resuscitation Equipment Kits, Resuscitation Equipment, ...
Sun Med imports and distributes finished medical devices. We are the global supplier of anesthesia, respiratory and urology accessories. We specialize in airway management products. We offer a complet more...
Deepak Products, Inc. | Address: 5220 N.W. 72nd Ave., Bay 15, Miami, Florida 33166, USA
www.deepakproducts.com | Send Inquiry | Phone: +1-(305)-482-9669
Products: Anesthetics, Disinfectants & Germicides, Topical Anesthetics, Nonresorbable Gauze/sponge for External Use (FDA Code: NAB), Medical Device, Sterilant (FDA Code: MED), Non-Sterile Absorbent Tipped Applicator (FDA Code: KXF), ...
Deepak Products, Inc. specializes in the manufacture of topical anesthetics, fluoride gels, fluoride foams and prophylaxis paste. Our Gelato topical anesthetic gel provides temporary relief of pain du more...
www.deepakproducts.com | Send Inquiry | Phone: +1-(305)-482-9669
Products: Anesthetics, Disinfectants & Germicides, Topical Anesthetics, Nonresorbable Gauze/sponge for External Use (FDA Code: NAB), Medical Device, Sterilant (FDA Code: MED), Non-Sterile Absorbent Tipped Applicator (FDA Code: KXF), ...
Deepak Products, Inc. specializes in the manufacture of topical anesthetics, fluoride gels, fluoride foams and prophylaxis paste. Our Gelato topical anesthetic gel provides temporary relief of pain du more...
Astron International Inc. | Address: 3410 Westview Dr., Naples, Florida 34104, USA
Phone: +1-(239)-435-0320
Products: Maddox Lens (FDA Code: HKR), Ophthalmic Eye Shield (FDA Code: HOY), Ophthalmic Prism Bar (FDA Code: HKW), Ophthalmic Rotary Prism (FDA Code: HKQ), Stereopsis Measuring Instrument (FDA Code: HLC), ...
Astron International Inc. is a manufacturer of ophthalmic medical devices and instruments. Our products include shield eye, ophthalmic sunlamp protective lamp, measuring stereopsis, lens, and maddox. more...
Phone: +1-(239)-435-0320
Products: Maddox Lens (FDA Code: HKR), Ophthalmic Eye Shield (FDA Code: HOY), Ophthalmic Prism Bar (FDA Code: HKW), Ophthalmic Rotary Prism (FDA Code: HKQ), Stereopsis Measuring Instrument (FDA Code: HLC), ...
Astron International Inc. is a manufacturer of ophthalmic medical devices and instruments. Our products include shield eye, ophthalmic sunlamp protective lamp, measuring stereopsis, lens, and maddox. more...
Medisafe America, LLC. | Address: 4710 Eisenhower Blvd., Suite B-4, Tampa, Florida 33634, USA
www.medisafeamerica.com | Send Inquiry | Phone: +1-(813)-886-1311, 877-444-6334
Products: Used Surgical Instruments, Eyewear, Surgical Instrument Tray (FDA Code: FSM), Medical Instrument Ultrasonic Cleaner (FDA Code: FLG), Ophthalmic Eye Shield (FDA Code: HOY), Endoscope Cleaning Brushes & Accessories (FDA Code: MNL), ...
Medisafe America, LLC. designs, develops and supplies equipment that reprocess complex & critical surgical instruments from a small practice to a major acute hospital. Sonic Irrigator SA is a tabletop more...
www.medisafeamerica.com | Send Inquiry | Phone: +1-(813)-886-1311, 877-444-6334
Products: Used Surgical Instruments, Eyewear, Surgical Instrument Tray (FDA Code: FSM), Medical Instrument Ultrasonic Cleaner (FDA Code: FLG), Ophthalmic Eye Shield (FDA Code: HOY), Endoscope Cleaning Brushes & Accessories (FDA Code: MNL), ...
Medisafe America, LLC. designs, develops and supplies equipment that reprocess complex & critical surgical instruments from a small practice to a major acute hospital. Sonic Irrigator SA is a tabletop more...
SHARN Anesthesia | Address: 4517 George Road, Suite 200, Tampa, Florida 33634, USA
www.sharn.com | Send Inquiry | Phone: +001-(813)-889-9614, 800-325-3671
FDA Registration: 1035845 Year Established: 1983 Annual Revenues: USD 5-10 Million Employee Count: ~40 Quality: CE Certified
Products: Aneroid Sphygmomanometer, Coin Operated Sphygmomanometer, Adjustable Sphygmomanometer, Anesthesia Machine Replacement Sensor, Conventional Nasal Cannula, Airway Mask Cleaning Brushes, ...
SHARN Anesthesia provides hospitals and surgery centers with quality anesthesia & other products. Our product list comprises of anesthesia accessories, atomizer, blood pressure cuffs, endotracheal tub more...
www.sharn.com | Send Inquiry | Phone: +001-(813)-889-9614, 800-325-3671
FDA Registration: 1035845 Year Established: 1983 Annual Revenues: USD 5-10 Million Employee Count: ~40 Quality: CE Certified
Products: Aneroid Sphygmomanometer, Coin Operated Sphygmomanometer, Adjustable Sphygmomanometer, Anesthesia Machine Replacement Sensor, Conventional Nasal Cannula, Airway Mask Cleaning Brushes, ...
SHARN Anesthesia provides hospitals and surgery centers with quality anesthesia & other products. Our product list comprises of anesthesia accessories, atomizer, blood pressure cuffs, endotracheal tub more...
United Medical Enterprises | Address: 4049 Allen Station Rd, Augusta, Georgia 30906, USA
Phone: +1-(757)-224-0177
FDA Registration: 1062201
Products: Gauze Sponges, Surgical Mask for Nurses, Surgical Masks (FDA Code: FXX), Cone Surgical Mask, One-Piece Scalpel (FDA Code: GDX), Surgical Respirator (FDA Code: MSH), ...
United Medical Enterprises is a manufacturer of surgical and medical instruments. We provide non woven gauze sponges, sterile and non sterile for external use. more...
Phone: +1-(757)-224-0177
FDA Registration: 1062201
Products: Gauze Sponges, Surgical Mask for Nurses, Surgical Masks (FDA Code: FXX), Cone Surgical Mask, One-Piece Scalpel (FDA Code: GDX), Surgical Respirator (FDA Code: MSH), ...
United Medical Enterprises is a manufacturer of surgical and medical instruments. We provide non woven gauze sponges, sterile and non sterile for external use. more...
Homeo Green, Inc. | Address: 875 Waimanu St., No. 626, Honolulu, Hawaii 96813, USA
Phone: +1-(808)-591-1660
Products: Adhesive Bandages (FDA Code: KGX), Clinical Mercury Thermometers (FDA Code: FLK), Ear Wick (FDA Code: KCN), Gas Mask Head Strap (FDA Code: BTK), Non-Sterile Absorbent Tipped Applicator (FDA Code: KXF), Drug Wound Dressing (FDA Code: FRO), ...
Homeo Green, Inc. is a distributor of bandages, menstural pads, thermometers and adhesive strips. We offer disposable hot packs, gas mask head straps, drug wound dressing, ear wicks, non-sterile absor more...
Phone: +1-(808)-591-1660
Products: Adhesive Bandages (FDA Code: KGX), Clinical Mercury Thermometers (FDA Code: FLK), Ear Wick (FDA Code: KCN), Gas Mask Head Strap (FDA Code: BTK), Non-Sterile Absorbent Tipped Applicator (FDA Code: KXF), Drug Wound Dressing (FDA Code: FRO), ...
Homeo Green, Inc. is a distributor of bandages, menstural pads, thermometers and adhesive strips. We offer disposable hot packs, gas mask head straps, drug wound dressing, ear wicks, non-sterile absor more...
CTP Coil Inc. | Address: 1801-D Howard Street, Elk Grove Village, Illinois 60007-2450, USA
www.coil.co.uk | Send Inquiry | Phone: +1-(847)-228-8818, 800-933-2645
Year Established: 1994 Annual Revenues: < USD 1 Million Quality: ISO 9000, ISO 9001, CE Certified
Products: AC-Powered Optical Vision Aid (FDA Code: HPI), Battery-Powered Optical Vision Aid (FDA Code: HPE), Low Power Binocular Loupe (FDA Code: HJH), Low-Vision Hand-Held Magnifier (FDA Code: HJF), Low-Vision Spectacle Telescope (FDA Code: HKK), Magnifying Spectacle (FDA Code: HOI), ...
CTP Coil Inc. manufactures precision low vision products. We serve the ophthalmic and industrial optics markets. We research, develop and manufacture low vision aid magnifiers. We provide various form more...
www.coil.co.uk | Send Inquiry | Phone: +1-(847)-228-8818, 800-933-2645
Year Established: 1994 Annual Revenues: < USD 1 Million Quality: ISO 9000, ISO 9001, CE Certified
Products: AC-Powered Optical Vision Aid (FDA Code: HPI), Battery-Powered Optical Vision Aid (FDA Code: HPE), Low Power Binocular Loupe (FDA Code: HJH), Low-Vision Hand-Held Magnifier (FDA Code: HJF), Low-Vision Spectacle Telescope (FDA Code: HKK), Magnifying Spectacle (FDA Code: HOI), ...
CTP Coil Inc. manufactures precision low vision products. We serve the ophthalmic and industrial optics markets. We research, develop and manufacture low vision aid magnifiers. We provide various form more...
Pro-Optics, Inc. | Address: 317 Woodwork Lane, Palatine, Illinois 60067, USA
pro-opticsinc.com | Send Inquiry | Phone: +1-(800)-323-3846
FDA Registration: 1419844 Annual Revenues: USD 1-5 Million Employee Count: ~80
Products: Occluders, Sport Eyewear Retainer, Lens Cleaner, Eye Patch, Ophthalmic Eye Shield (FDA Code: HOY), Pinhole Occluders, ...
Pro-Optics, Inc. specializes in optical accessories. We manufacture repair kits, eye patches, magnifiers, sunglasses, liquid cleaners, thermal cases for lenses, nose and temple pads, eyeglass holders more...
pro-opticsinc.com | Send Inquiry | Phone: +1-(800)-323-3846
FDA Registration: 1419844 Annual Revenues: USD 1-5 Million Employee Count: ~80
Products: Occluders, Sport Eyewear Retainer, Lens Cleaner, Eye Patch, Ophthalmic Eye Shield (FDA Code: HOY), Pinhole Occluders, ...
Pro-Optics, Inc. specializes in optical accessories. We manufacture repair kits, eye patches, magnifiers, sunglasses, liquid cleaners, thermal cases for lenses, nose and temple pads, eyeglass holders more...
Podz Eyewear, Inc. | Address: 1100 SW Wanamaker , Suite 10, Topeka, Kansas 66606, USA
www.podzeyewear.com | Send Inquiry | Phone: +1-(785)-536-3393
FDA Registration: 3007119974
Products: Glasses, Protective Eyewear, Eyewear, Ophthalmic Eye Shield (FDA Code: HOY), Lens, Protective Tanning Lenses, ...
Podz Eyewear, Inc manufactures protective tanning lenses. Our lens comprises of chrome Podz™, Lenz, private labeled Podz™ and Gold Podz™. Our Podz™ are available in assorted co more...
www.podzeyewear.com | Send Inquiry | Phone: +1-(785)-536-3393
FDA Registration: 3007119974
Products: Glasses, Protective Eyewear, Eyewear, Ophthalmic Eye Shield (FDA Code: HOY), Lens, Protective Tanning Lenses, ...
Podz Eyewear, Inc manufactures protective tanning lenses. Our lens comprises of chrome Podz™, Lenz, private labeled Podz™ and Gold Podz™. Our Podz™ are available in assorted co more...
KBD, Inc. | Address: 2550 American Ct., Crescent Springs, Kentucky 41017, USA
www.sperti.com | Send Inquiry | Phone: +1-(859)-331-0800, 800-544-3757
FDA Registration: 1022129
Products: Therapeutic Heating Infrared Lamp (FDA Code: ILY), TInfrared Light (FDA Code: ILY), Dermatological Ultraviolet Light (FDA Code: FTC), Ophthalmic Eye Shield (FDA Code: HOY), Non Heating Infrared Lamp (FDA Code: IOB), Vitamin-D Ultraviolet Lamps, ...
KBD, Inc. specializes in healthcare products. Our KBD D/UV Vitamin D ultraviolet lamp that produces UV rays similar to sunlight helps the body generate vitamin D without tanning. UV light exposure for more...
www.sperti.com | Send Inquiry | Phone: +1-(859)-331-0800, 800-544-3757
FDA Registration: 1022129
Products: Therapeutic Heating Infrared Lamp (FDA Code: ILY), TInfrared Light (FDA Code: ILY), Dermatological Ultraviolet Light (FDA Code: FTC), Ophthalmic Eye Shield (FDA Code: HOY), Non Heating Infrared Lamp (FDA Code: IOB), Vitamin-D Ultraviolet Lamps, ...
KBD, Inc. specializes in healthcare products. Our KBD D/UV Vitamin D ultraviolet lamp that produces UV rays similar to sunlight helps the body generate vitamin D without tanning. UV light exposure for more...
Olsen Medical | Address: 3230 Commerce Center Place, Louisville, Kentucky 40211, USA
www.olsenmedical.com | Send Inquiry | Phone: +1-(502)-772-4280, 800-297-6344
FDA Registration: 1530493 Year Established: 1880 Employee Count: ~50 Quality: ISO 9001:2000, CE, ISO 13485, CMDCAS Certified
Products: Bipolar Irrigating Forceps, Forceps, Bipolar, Electrosurgical Cutting and Coagulation Device (FDA Code: GEI), Disposable Surgical Instrument (FDA Code: KDC), General & Plastic Surgery Surgical Clamp (FDA Code: GDJ), Electrosurgical Apparatus (FDA Code: HAM), ...
Olsen Medical designs, develops and manufactures electrosurgical instruments & accessory items. We manufacture a full line of bipolar and monopolar forceps including single use and reusable irrigating more...
www.olsenmedical.com | Send Inquiry | Phone: +1-(502)-772-4280, 800-297-6344
FDA Registration: 1530493 Year Established: 1880 Employee Count: ~50 Quality: ISO 9001:2000, CE, ISO 13485, CMDCAS Certified
Products: Bipolar Irrigating Forceps, Forceps, Bipolar, Electrosurgical Cutting and Coagulation Device (FDA Code: GEI), Disposable Surgical Instrument (FDA Code: KDC), General & Plastic Surgery Surgical Clamp (FDA Code: GDJ), Electrosurgical Apparatus (FDA Code: HAM), ...
Olsen Medical designs, develops and manufactures electrosurgical instruments & accessory items. We manufacture a full line of bipolar and monopolar forceps including single use and reusable irrigating more...
Ophthalmic Surgical LLC | Address: 76825 Jessie Romig Dr., Grosse Tete, Louisiana 70740, USA
www.ophthalmicsurgical.com | Send Inquiry | Phone: +1-(225)-921-0971
Products: Lacrimal Probes (FDA Code: HNL), Lacrimal Dilator (FDA Code: HNW), Corneal Radius Measurement Instrument (FDA Code: HJB), Corneo-Scleral Punch (FDA Code: HNJ), Intraocular Lens Guide (FDA Code: KYB), Iris Retractor Clip (FDA Code: HOC), ...
Ophthalmic Surgical LLC is engaged in the production of surgical instruments. Our products include calipers and gauges, cannulas, DCR instruments, diamond knives, enucleation & evisceration instrument more...
www.ophthalmicsurgical.com | Send Inquiry | Phone: +1-(225)-921-0971
Products: Lacrimal Probes (FDA Code: HNL), Lacrimal Dilator (FDA Code: HNW), Corneal Radius Measurement Instrument (FDA Code: HJB), Corneo-Scleral Punch (FDA Code: HNJ), Intraocular Lens Guide (FDA Code: KYB), Iris Retractor Clip (FDA Code: HOC), ...
Ophthalmic Surgical LLC is engaged in the production of surgical instruments. Our products include calipers and gauges, cannulas, DCR instruments, diamond knives, enucleation & evisceration instrument more...
Aqua Leisure Industries, Inc. | Address: 525 Bodwell Street, Avon, Massachusetts 02322, USA
www.aqualeisure.com | Send Inquiry | Phone: +1-(866)-807-3998
FDA Registration: 1221480
Products: Exercise Products, Swim Training Aids, Fitness Accessories, Rehab & Fitness Equipment, Sun Protection Kits, Ophthalmic Eye Shield (FDA Code: HOY), Sun Shade and Protection Gears, ...
Aqua Leisure Industries, Inc. is engaged in the production of fitness products for children. Our brands include First Fitness®, and SunSmart® products. First Fitness products are used to incre more...
www.aqualeisure.com | Send Inquiry | Phone: +1-(866)-807-3998
FDA Registration: 1221480
Products: Exercise Products, Swim Training Aids, Fitness Accessories, Rehab & Fitness Equipment, Sun Protection Kits, Ophthalmic Eye Shield (FDA Code: HOY), Sun Shade and Protection Gears, ...
Aqua Leisure Industries, Inc. is engaged in the production of fitness products for children. Our brands include First Fitness®, and SunSmart® products. First Fitness products are used to incre more...
Becton Dickinson And Co. | Address: 411 Waverley Oaks Rd., Waltham, Massachusetts 02452-8405, USA
www.bd.com/ophthalmology | Send Inquiry | Phone: +1-(781)-906-7900, 866-906-8080
FDA Registration: 1211998 Annual Revenues: USD 10-25 Million Employee Count: ~200
Products: Disposable Ophthalmic Cannulae, Dissecting Scalpel Blades, Cataract Knife, Culture Media Supplements (FDA Code: JSK), Cystotome (FDA Code: HNY), Bone Cutting Blade, ...
Our products focus on cataract, refractive, surgery kits and other surgical products. Our cataract products include blades, knives, cannules, cystotomes, drapes, and fluid collection. Our surgical pro more...
www.bd.com/ophthalmology | Send Inquiry | Phone: +1-(781)-906-7900, 866-906-8080
FDA Registration: 1211998 Annual Revenues: USD 10-25 Million Employee Count: ~200
Products: Disposable Ophthalmic Cannulae, Dissecting Scalpel Blades, Cataract Knife, Culture Media Supplements (FDA Code: JSK), Cystotome (FDA Code: HNY), Bone Cutting Blade, ...
Our products focus on cataract, refractive, surgery kits and other surgical products. Our cataract products include blades, knives, cannules, cystotomes, drapes, and fluid collection. Our surgical pro more...
Vascular Performance Products, LLC. | Address: 6945 Southbelt Dr., Se, Caledonia, Michigan 49316, USA
Phone: +1-(888)-364-7004 255
Products: Ophthalmic Eye Shield (FDA Code: HOY), Personnel Protective Shield (FDA Code: KPY), ...
Vascular Performance Products, LLC. manufactures personnel protective shields. more...
Phone: +1-(888)-364-7004 255
Products: Ophthalmic Eye Shield (FDA Code: HOY), Personnel Protective Shield (FDA Code: KPY), ...
Vascular Performance Products, LLC. manufactures personnel protective shields. more...
LT Acquisition, Inc. | Address: 4489 East Paris Ave., Grand Rapids, Michigan 49512, USA
Phone: +1-(616)-698-1830
FDA Registration: 1835044
Products: Eyewear, Ophthalmic Eye Shield (FDA Code: HOY), Radiological Eye Shield (FDA Code: IWS), ...
LT Acquisition, Inc. specializes in providing tanning booth and disposable protective eyewear. more...
Phone: +1-(616)-698-1830
FDA Registration: 1835044
Products: Eyewear, Ophthalmic Eye Shield (FDA Code: HOY), Radiological Eye Shield (FDA Code: IWS), ...
LT Acquisition, Inc. specializes in providing tanning booth and disposable protective eyewear. more...
Jardon Eye Prosthetics, Inc. | Address: 15920 W 12 Mile Road, Southfield, Michigan 48076-2115, USA
jardoneye.com | Send Inquiry | Phone: +1-(248)-424-8560
FDA Registration: 1824736 Annual Revenues: < USD 1 Million
Products: Symblepharon Rings, Surgical Eye Shields, Ophthalmics Symblepharon Rings, Eye Sphere Implant (FDA Code: HPZ), Ophthalmic Conformer (FDA Code: HQN), Ophthalmic Eye Shield (FDA Code: HOY), ...
Jardon Eye Prosthetics Inc. manufactures custom eyes, surgical eye shields and silicone orbital implants. Our product area includes veterinary implants, human implants and ophthalmic devices. Our sili more...
jardoneye.com | Send Inquiry | Phone: +1-(248)-424-8560
FDA Registration: 1824736 Annual Revenues: < USD 1 Million
Products: Symblepharon Rings, Surgical Eye Shields, Ophthalmics Symblepharon Rings, Eye Sphere Implant (FDA Code: HPZ), Ophthalmic Conformer (FDA Code: HQN), Ophthalmic Eye Shield (FDA Code: HOY), ...
Jardon Eye Prosthetics Inc. manufactures custom eyes, surgical eye shields and silicone orbital implants. Our product area includes veterinary implants, human implants and ophthalmic devices. Our sili more...
Apothecary Products, Inc. | Address: 11750 12th Ave South, Burnsville, Minnesota 55337-1295, USA
www.apothecaryproducts.com | Send Inquiry | Phone: +1-(800)-328-2742
FDA Registration: 2183416 Year Established: 1975 Annual Revenues: USD 25-50 Million Employee Count: ~130
Products: Splints, Boxes, Glass & Plastic Bottles, General Medical Supplies, Turnkey Glove Boxes, Polymer Glove Boxes, ...
Apothecary Products, Inc. distributes pharmacy supplies. We deliver retail products in a variety of categories like medical compliance aids, health & beauty care, baby care and travel accessories. Our more...
www.apothecaryproducts.com | Send Inquiry | Phone: +1-(800)-328-2742
FDA Registration: 2183416 Year Established: 1975 Annual Revenues: USD 25-50 Million Employee Count: ~130
Products: Splints, Boxes, Glass & Plastic Bottles, General Medical Supplies, Turnkey Glove Boxes, Polymer Glove Boxes, ...
Apothecary Products, Inc. distributes pharmacy supplies. We deliver retail products in a variety of categories like medical compliance aids, health & beauty care, baby care and travel accessories. Our more...
Fresnel Prism & Lens Co. | Address: 6824 Washington Avenue.s, Eden Prairie, Minnesota 55344, USA
www.fresnel-prism.com | Send Inquiry | Phone: +1-(800)-544-4760
FDA Registration: 2086350
Products: Occlusion Lens, Ophthalmic Eye Shield (FDA Code: HOY), Ophthalmic Fresnel Prism (FDA Code: HKT), Ophthalmic Trial Lens Set (FDA Code: HPC), Occlusion Eye Patch, Night Driving Glasses, ...
Fresnel Prism & Lens Co. specializes in diagnostic, therapeutic and general products. The Pedi-Wrap™ is intended to cover the full length of the patient's arm. They immobilizes elbow to prevent more...
www.fresnel-prism.com | Send Inquiry | Phone: +1-(800)-544-4760
FDA Registration: 2086350
Products: Occlusion Lens, Ophthalmic Eye Shield (FDA Code: HOY), Ophthalmic Fresnel Prism (FDA Code: HKT), Ophthalmic Trial Lens Set (FDA Code: HPC), Occlusion Eye Patch, Night Driving Glasses, ...
Fresnel Prism & Lens Co. specializes in diagnostic, therapeutic and general products. The Pedi-Wrap™ is intended to cover the full length of the patient's arm. They immobilizes elbow to prevent more...
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FDA Code / Regulation: HOY / 886.4750
An ophthalmic eye shield is a device that consists of a plastic or aluminum eye covering intended to protect the eye or retain dressing materials in place.
Classification. Class I (general controls). When made only of plastic or aluminum, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 886.9. When made only of plastic or aluminum, the devices are exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180 of this chapter, with respect to general requirements concerning records, and 820.198 of this chapter, with respect to complaint files.
