Compression Dressing Suppliers
Limit companies to: Worldwide USA
Synergy Health Plc. | Address: Ground Floor Stella, Windmill Hill Business Park, Whitehill Way, Swindon SN5 6NX, United Kingdom 
www.synergyhealthplc.com | Send Inquiry | Phone: +44-(1772)-299900, 299999
Annual Revenues: USD 50-100 Million Employee Count: ~400 Quality: ISO 9001, CE Certified
Products: Adult Diapers and Underpads, Adult Diaper, Briefs Adult Diapers, Adult Diaper Fitted Briefs, Antiseptic Swabs, Cast, ...
Synergy Health Plc. delivers a range of specialist outsourced services to healthcare providers and other clients concerned with health management. Our product solutions are infection prevention, patie more...
www.synergyhealthplc.com | Send Inquiry | Phone: +44-(1772)-299900, 299999
Annual Revenues: USD 50-100 Million Employee Count: ~400 Quality: ISO 9001, CE Certified
Products: Adult Diapers and Underpads, Adult Diaper, Briefs Adult Diapers, Adult Diaper Fitted Briefs, Antiseptic Swabs, Cast, ...
Synergy Health Plc. delivers a range of specialist outsourced services to healthcare providers and other clients concerned with health management. Our product solutions are infection prevention, patie more...
Lantor (UK), Ltd. | Address: St. Helens Rd., Bolton BL3 3PR, United Kingdom
www.lantor.co.uk | Send Inquiry | Phone: +44-(1204)-855-000
FDA Registration: 8021899
Products: Ulcer, Burn & Wound Dressings, Wound Dressings, Wound Care Dressings, Casting Padding Kits, Orthopedic Casting Tape, Cast Bandage (FDA Code: ITG), ...
Lantor (UK), Ltd. is engaged in the production of clinical products. Our products include surgical, wound & first aid dressings, and orthopedic paddings. We also offer products for compression therapy more...
www.lantor.co.uk | Send Inquiry | Phone: +44-(1204)-855-000
FDA Registration: 8021899
Products: Ulcer, Burn & Wound Dressings, Wound Dressings, Wound Care Dressings, Casting Padding Kits, Orthopedic Casting Tape, Cast Bandage (FDA Code: ITG), ...
Lantor (UK), Ltd. is engaged in the production of clinical products. Our products include surgical, wound & first aid dressings, and orthopedic paddings. We also offer products for compression therapy more...
Robinson Healthcare Limited | Address: Waterside, Walton, Chesterfield, Derbyshire S40 1YF, United Kingdom
www.robinson.uk.com | Send Inquiry | Phone: +44-(1246)-220-022
Annual Revenues: USD 50-100 Million Employee Count: ~520 Quality: ISO 9002, CE Certified
Products: Adhesive Bandages (FDA Code: KGX), Adhesive Elastic Bandage Tape, Adult Diaper, Adhesive Bandage Strip, Adhesive Gauze Bandage, Absorbable Gauze, Dressing, ...
Robinson Healthcare Limited is a supplier of washable incontinence products. Some of our products are incontinence briefs, reusable incontinence underwear, sterile emergency dressing, veterinary, adhe more...
www.robinson.uk.com | Send Inquiry | Phone: +44-(1246)-220-022
Annual Revenues: USD 50-100 Million Employee Count: ~520 Quality: ISO 9002, CE Certified
Products: Adhesive Bandages (FDA Code: KGX), Adhesive Elastic Bandage Tape, Adult Diaper, Adhesive Bandage Strip, Adhesive Gauze Bandage, Absorbable Gauze, Dressing, ...
Robinson Healthcare Limited is a supplier of washable incontinence products. Some of our products are incontinence briefs, reusable incontinence underwear, sterile emergency dressing, veterinary, adhe more...
Frank Sammeroff Ltd. | Address: 131 Woodhead Road, South Nitshill, Glasgow G53 7NN, United Kingdom
www.sammeroff.co.uk | Send Inquiry | Phone: +44-(141)-881-5701
Year Established: 1939 Annual Revenues: USD 1-5 Million Employee Count: ~40 Quality: ISO 9002, CE Certified
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), ...
Frank Sammeroff Ltd. deals with surgical supplies. Our product portfolio comprises of first aid kits, empty boxes & pouches, dressings & bandages, adhesive plasters & tapes, eyecare & burn care and fi more...
www.sammeroff.co.uk | Send Inquiry | Phone: +44-(141)-881-5701
Year Established: 1939 Annual Revenues: USD 1-5 Million Employee Count: ~40 Quality: ISO 9002, CE Certified
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), ...
Frank Sammeroff Ltd. deals with surgical supplies. Our product portfolio comprises of first aid kits, empty boxes & pouches, dressings & bandages, adhesive plasters & tapes, eyecare & burn care and fi more...
Steroplast Limited | Address: Alpha Point, Bradnor Road, Manchester,, M22 4te, England, Manchester, GB-MAN n/a, United Kingdom
www.steroplast.co.uk | Send Inquiry | Phone: +44-(0161)-902 3030
Products: Oxygen Masks (FDA Code: BYG), Absorbent Cotton Wool, First Aid Kits, Compression Dressing (FDA Code: MHW), Emergency First Aid Kit (FDA Code: LRR), Disposable Oxygen Masks, ...
Steroplast Limited is a distributor of diagnostic equipment. We are an ISO 13485:2003 certified company. Our foil survival blanket is ideal for treating or preventing hypothermia after first aid has b more...
www.steroplast.co.uk | Send Inquiry | Phone: +44-(0161)-902 3030
Products: Oxygen Masks (FDA Code: BYG), Absorbent Cotton Wool, First Aid Kits, Compression Dressing (FDA Code: MHW), Emergency First Aid Kit (FDA Code: LRR), Disposable Oxygen Masks, ...
Steroplast Limited is a distributor of diagnostic equipment. We are an ISO 13485:2003 certified company. Our foil survival blanket is ideal for treating or preventing hypothermia after first aid has b more...
Allegiance Healthcare (thailand) Limited | Address: 7/111 Moo 4 Highway# 331, Mabyangporn, Pluakdaeng, Rayong 21140, Thailand
Send Inquiry | Phone: +66-(38)-956-155-62
FDA Registration: 9615914
Products: Infusion Stand (FDA Code: FOX), Disposable Surgical Instrument (FDA Code: KDC), Disposable Surgical Instrument Kit (FDA Code: KDD), Operating Room Scrub Brush (FDA Code: GEC), Surgeon's Gloves (FDA Code: KGO), Reusable Hot /Cold Pack (FDA Code: IME), ...
Allegiance Healthcare (Thailand) Limited, is a manufacturer of surgical and medical gloves. more...
Send Inquiry | Phone: +66-(38)-956-155-62
FDA Registration: 9615914
Products: Infusion Stand (FDA Code: FOX), Disposable Surgical Instrument (FDA Code: KDC), Disposable Surgical Instrument Kit (FDA Code: KDD), Operating Room Scrub Brush (FDA Code: GEC), Surgeon's Gloves (FDA Code: KGO), Reusable Hot /Cold Pack (FDA Code: IME), ...
Allegiance Healthcare (Thailand) Limited, is a manufacturer of surgical and medical gloves. more...
Cederroth Industrial Products AB | Address: PO Box 715,Kanalvagen 5a, Upplands Vasby SE-194 27, Sweden
www.firstaid.cederroth.com | Send Inquiry | Phone: +46-(8)-590 309 53
Quality: ISO 13485:2003 Certified
Products: Adhesive Bandages (FDA Code: KGX), Compression Dressing (FDA Code: MHW), Travel First Aid Kit with Drug (FDA Code: LRR), Emergency First Aid Kit (FDA Code: LRR), Nonresorbable Gauze/sponge for External Use (FDA Code: NAB), Ocular Surgery Irrigation Device (FDA Code: KYG), ...
Cederroth Industrial Products AB manufactures and markets first aid products for workplaces. Our product line includes eye wash, first aid panel, mini first aid panel, 4-in-1 blood stopper, 4-in-1 min more...
www.firstaid.cederroth.com | Send Inquiry | Phone: +46-(8)-590 309 53
Quality: ISO 13485:2003 Certified
Products: Adhesive Bandages (FDA Code: KGX), Compression Dressing (FDA Code: MHW), Travel First Aid Kit with Drug (FDA Code: LRR), Emergency First Aid Kit (FDA Code: LRR), Nonresorbable Gauze/sponge for External Use (FDA Code: NAB), Ocular Surgery Irrigation Device (FDA Code: KYG), ...
Cederroth Industrial Products AB manufactures and markets first aid products for workplaces. Our product line includes eye wash, first aid panel, mini first aid panel, 4-in-1 blood stopper, 4-in-1 min more...
Laboratorios Le Roy | Address: Azucar No. 107, Col. Granzas 08400, Mexico
www.leroy.com.mx | Send Inquiry | Phone: +52-(55)-50109100
FDA Registration: 3000256895 Quality: ISO13485 Certified
Products: Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), Compression Dressing (FDA Code: MHW), Medical Support Stocking (FDA Code: FQL), Skin Protectant Liquid Bandage (FDA Code: NEC), Drug Wound Dressing (FDA Code: FRO), ...
Laboratorios Le Roy provides bandages & medical supplies, orthopedic aids and disposable clothing for hospital use. We offer elastic bandages such as valuelastic, midlastic, supreme, elastomedic, tech more...
www.leroy.com.mx | Send Inquiry | Phone: +52-(55)-50109100
FDA Registration: 3000256895 Quality: ISO13485 Certified
Products: Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), Compression Dressing (FDA Code: MHW), Medical Support Stocking (FDA Code: FQL), Skin Protectant Liquid Bandage (FDA Code: NEC), Drug Wound Dressing (FDA Code: FRO), ...
Laboratorios Le Roy provides bandages & medical supplies, orthopedic aids and disposable clothing for hospital use. We offer elastic bandages such as valuelastic, midlastic, supreme, elastomedic, tech more...
Lee & Oh International Inc. | Address: 82-4 Sungdong-Ri, Thanhyun-Myoun, Paju-City, KR-41 413-841, Korea, Republic Of 
Products: Elastic Bandages (FDA Code: FQM), Compression Dressing (FDA Code: MHW), Medical Support Stocking (FDA Code: FQL), ...
Lee & Oh International Inc. supplies elastic bandages and synthetic socks. more...
Products: Elastic Bandages (FDA Code: FQM), Compression Dressing (FDA Code: MHW), Medical Support Stocking (FDA Code: FQL), ...
Lee & Oh International Inc. supplies elastic bandages and synthetic socks. more...
Pietrasanta Pharma S.R.L. | Address: Via S. Francesco No 67, Viareggio 55049, Italy
Phone: +39-(584)-49855
FDA Registration: 9617582
Products: Adhesive Bandages (FDA Code: KGX), Eye Pads, Compression Dressing (FDA Code: MHW), Oval Eye Pads (FDA Code: HMP), Eye Pads Dressing Sponges, Ophthalmic Eye Pad (FDA Code: HMP), ...
Pietrasanta Pharma S.R.L. offers orthoptic eye patch. more...
Phone: +39-(584)-49855
FDA Registration: 9617582
Products: Adhesive Bandages (FDA Code: KGX), Eye Pads, Compression Dressing (FDA Code: MHW), Oval Eye Pads (FDA Code: HMP), Eye Pads Dressing Sponges, Ophthalmic Eye Pad (FDA Code: HMP), ...
Pietrasanta Pharma S.R.L. offers orthoptic eye patch. more...
Lm First Aid Products Pvt Ltd | Address: 3/395 Mookambiga Nagar, Kattupakkam, Chennai, Tamil Nadu 600045, India 
Phone: +91-(727)-4492150
Products: Travel First Aid Kit with Drug (FDA Code: LRR), Emergency First Aid Kit (FDA Code: LRR), Chemical Color Change Thermometer (FDA Code: FQZ), Vinyl Patient Examination Glove (FDA Code: LYZ), Non-Sterile External Non-Inflatable Extremity Splint (FDA Code: NOC), Non-Sterile Specimen Container (FDA Code: NNI), ...
Lm First Aid Products Pvt Ltd offers first aid kits, medical disposables, medical dressings, emergency preparedness/first responder kits, gauze dressings and gloves-latex vinyl & nitrile. We provide a more...
Phone: +91-(727)-4492150
Products: Travel First Aid Kit with Drug (FDA Code: LRR), Emergency First Aid Kit (FDA Code: LRR), Chemical Color Change Thermometer (FDA Code: FQZ), Vinyl Patient Examination Glove (FDA Code: LYZ), Non-Sterile External Non-Inflatable Extremity Splint (FDA Code: NOC), Non-Sterile Specimen Container (FDA Code: NNI), ...
Lm First Aid Products Pvt Ltd offers first aid kits, medical disposables, medical dressings, emergency preparedness/first responder kits, gauze dressings and gloves-latex vinyl & nitrile. We provide a more...
Liv Medica Equipments Private Limited | Address: B-26, Phase Ii, Mepz, Thambaram, Chennai, Tamil Nadu 600 045, India
www.livmedica.in | Send Inquiry | Phone: +91-(44)-22621231
Products: Adhesive Bandages (FDA Code: KGX), Arm Slings (FDA Code: ILI), Compression Dressing (FDA Code: MHW), Adult Tongue Depressor (FDA Code: FMA), Disposable Medical Bed (FDA Code: KME), Disposable Hot/Cold Pack (FDA Code: IMD), ...
Liv Medica Equipments Pvt. Ltd supplies first aid kits, components and medical disposals. Our products include non-rebreathing oxygen masks, non-sterile specimen containers, elastic bandages, non-ster more...
www.livmedica.in | Send Inquiry | Phone: +91-(44)-22621231
Products: Adhesive Bandages (FDA Code: KGX), Arm Slings (FDA Code: ILI), Compression Dressing (FDA Code: MHW), Adult Tongue Depressor (FDA Code: FMA), Disposable Medical Bed (FDA Code: KME), Disposable Hot/Cold Pack (FDA Code: IMD), ...
Liv Medica Equipments Pvt. Ltd supplies first aid kits, components and medical disposals. Our products include non-rebreathing oxygen masks, non-sterile specimen containers, elastic bandages, non-ster more...
Paul Hartmann AG | Address: Paul-Hartmann-str. 12, Heidenheim 89522, Germany 
de.hartmann.info | Send Inquiry | Phone: +49-(7321)-36-0
FDA Registration: 8010690 Employee Count: ~7000 Quality: ISO 9001 Certified
Products: Adhesive Bandages (FDA Code: KGX), Elastic Adhesive Bandages, Adhesive Bandage Strip, Adhesive Gauze Bandage, Cast Component (FDA Code: LGF), Incontinence Protective Garment (FDA Code: EYQ), ...
Paul Hartmann AG focuses on the provision of system solutions for professionals in both medicine and nursing. Our focal areas are wound care, incontinence care and risk protection in the operating roo more...
de.hartmann.info | Send Inquiry | Phone: +49-(7321)-36-0
FDA Registration: 8010690 Employee Count: ~7000 Quality: ISO 9001 Certified
Products: Adhesive Bandages (FDA Code: KGX), Elastic Adhesive Bandages, Adhesive Bandage Strip, Adhesive Gauze Bandage, Cast Component (FDA Code: LGF), Incontinence Protective Garment (FDA Code: EYQ), ...
Paul Hartmann AG focuses on the provision of system solutions for professionals in both medicine and nursing. Our focal areas are wound care, incontinence care and risk protection in the operating roo more...
Lohmann & Rauscher GmbH & Co. KG | Address: Irlicher Strasse 55, Neuwied D-56567, Germany
www.lohmann-rauscher.com | Send Inquiry | Phone: +49-(2634)-99-0
FDA Registration: 9611462 Annual Revenues: USD 100-500 Million Employee Count: ~2800 Quality: ISO 9001, CE Certified
Products: Breast Pumps, Face Masks, Adhesive Bandages (FDA Code: KGX), Eye Patch, Adhesive Tape, Bandage Clip, ...
Lohmann & Rauscher GmbH & Co. KG offers a variety of high-quality classic medical products, modern therapy-adjusted systems & system solutions as well as offer service in the core business segments su more...
www.lohmann-rauscher.com | Send Inquiry | Phone: +49-(2634)-99-0
FDA Registration: 9611462 Annual Revenues: USD 100-500 Million Employee Count: ~2800 Quality: ISO 9001, CE Certified
Products: Breast Pumps, Face Masks, Adhesive Bandages (FDA Code: KGX), Eye Patch, Adhesive Tape, Bandage Clip, ...
Lohmann & Rauscher GmbH & Co. KG offers a variety of high-quality classic medical products, modern therapy-adjusted systems & system solutions as well as offer service in the core business segments su more...
Gomez Sarante Manufacturing | Address: Autopista Joaquin Balaguer Km. 5 1/2, Zona Franca Pisano, Nave No. 29, Santiago, Dominican Republic
Phone: +829-(973)-5699500-215
Products: Compression Dressing (FDA Code: MHW), Incontinence Protective Garment (FDA Code: EYQ), Scented-Deodorized Menstrual Pads (FDA Code: NRC), ...
Gomez Sarante Manufacturing specializes in the production of compression dressings, incontinence protective garments and scented-deodorized menstrual pads. more...
Phone: +829-(973)-5699500-215
Products: Compression Dressing (FDA Code: MHW), Incontinence Protective Garment (FDA Code: EYQ), Scented-Deodorized Menstrual Pads (FDA Code: NRC), ...
Gomez Sarante Manufacturing specializes in the production of compression dressings, incontinence protective garments and scented-deodorized menstrual pads. more...
Davis And Geck Caribe, Ltd. | Address: Zona Franca De San Isidro, Carretara San Isidro Km 17, Santo Domingo, Dominican Republic
Phone: 203-845-1000
FDA Registration: 9612501
Products: Non Dental Irrigating Syringe (FDA Code: KYZ), Monofilament & Multifilament Steel Non-Absorbable Suture (FDA Code: GAQ), Polyamide Synthetic Non-Absorbable Suture (FDA Code: GAR), Polyethylene Synthetic Non-Absorbable Suture (FDA Code: GAT), Polypropylene Synthetic Non-Absorbable Suture (FDA Code: GAW), Silk Non-Absorbable Suture (FDA Code: GAP), ...
Davis And Geck Caribe, Ltd. specializes in the production of polytetrafluorethylene pledget, disposable endoscopic specimen pouch, steel sutures and umbilical tape-sterile round cotton tape. more...
Phone: 203-845-1000
FDA Registration: 9612501
Products: Non Dental Irrigating Syringe (FDA Code: KYZ), Monofilament & Multifilament Steel Non-Absorbable Suture (FDA Code: GAQ), Polyamide Synthetic Non-Absorbable Suture (FDA Code: GAR), Polyethylene Synthetic Non-Absorbable Suture (FDA Code: GAT), Polypropylene Synthetic Non-Absorbable Suture (FDA Code: GAW), Silk Non-Absorbable Suture (FDA Code: GAP), ...
Davis And Geck Caribe, Ltd. specializes in the production of polytetrafluorethylene pledget, disposable endoscopic specimen pouch, steel sutures and umbilical tape-sterile round cotton tape. more...
Taizhou Kanglin Health Produces Co. Ltd. | Address: Qi Li Bridge West,Economic, District, Taizhou City, Jiangsu Province, China 
Phone: +86-(523)-6663456
Products: Adhesive Bandages (FDA Code: KGX), Oval Eye Pads (FDA Code: HMP), Ophthalmic Eye Pad (FDA Code: HMP), Nonresorbable Gauze/sponge for External Use (FDA Code: NAB), Internal Gauze/Sponge (FDA Code: EFQ), Non-Surgical Isolation Gown (FDA Code: OEA), ...
Taizhou Kanglin Health Produces Co. Ltd. deals with various types of bandages and sponges. Our product line includes adhesive bandages, cast bandages, internal sponges, elastic bandages, mattress cove more...
Phone: +86-(523)-6663456
Products: Adhesive Bandages (FDA Code: KGX), Oval Eye Pads (FDA Code: HMP), Ophthalmic Eye Pad (FDA Code: HMP), Nonresorbable Gauze/sponge for External Use (FDA Code: NAB), Internal Gauze/Sponge (FDA Code: EFQ), Non-Surgical Isolation Gown (FDA Code: OEA), ...
Taizhou Kanglin Health Produces Co. Ltd. deals with various types of bandages and sponges. Our product line includes adhesive bandages, cast bandages, internal sponges, elastic bandages, mattress cove more...
Jiangsu Radiation Science & Technology Co., Ltd | Address: 50 Zhongling Road, Xiaolingwei, Nanjing 210014, China
Phone: +86-(25)-84390430
Products: Adhesive Bandages (FDA Code: KGX), Compression Dressing (FDA Code: MHW), ...
Jiangsu Radiation Science & Technology Co., Ltd deals with adhesive bandages and compression dressings. more...
Phone: +86-(25)-84390430
Products: Adhesive Bandages (FDA Code: KGX), Compression Dressing (FDA Code: MHW), ...
Jiangsu Radiation Science & Technology Co., Ltd deals with adhesive bandages and compression dressings. more...
Planet (hong Kong) International Co., Ltd. | Address: Rm. 805-807, Tong Da Mansion, No.1, Lane 600, Tian Shan Rd, Shanghai 200051, China
planethk.en.alibaba.com | Phone: +86-(21)-61136398
FDA Registration: 3004939558 Year Established: 2004 Employee Count: ~50
Products: Ice Bags (FDA Code: KYR), Travel First Aid Kit with Drug (FDA Code: LRR), Emergency First Aid Kit (FDA Code: LRR), Patient Examination Glove (FDA Code: FMC), Hydrogel Wound Dressing (W/Out Drug And/Or Biologic) (FDA Code: NAE), Skin Protectant Liquid Bandage (FDA Code: NEC), ...
Planet (hong Kong) International Co., Ltd. specializes in producing first aid associated products, and also offer private label programs or OEM service for a wide variety of first aid products. Our pr more...
planethk.en.alibaba.com | Phone: +86-(21)-61136398
FDA Registration: 3004939558 Year Established: 2004 Employee Count: ~50
Products: Ice Bags (FDA Code: KYR), Travel First Aid Kit with Drug (FDA Code: LRR), Emergency First Aid Kit (FDA Code: LRR), Patient Examination Glove (FDA Code: FMC), Hydrogel Wound Dressing (W/Out Drug And/Or Biologic) (FDA Code: NAE), Skin Protectant Liquid Bandage (FDA Code: NEC), ...
Planet (hong Kong) International Co., Ltd. specializes in producing first aid associated products, and also offer private label programs or OEM service for a wide variety of first aid products. Our pr more...
Aid United International Co., Limited | Address: Room 520, No. 1065, Wuzhong Road, Shanghai 201103, China
Phone: +86-(21)-64061944
FDA Registration: 3005951403
Products: Ice Bags (FDA Code: KYR), Compression Dressing (FDA Code: MHW), Oval Eye Pads (FDA Code: HMP), Ophthalmic Eye Pad (FDA Code: HMP), Nonresorbable Gauze/sponge for External Use (FDA Code: NAB), Hydrogel Wound Dressing (W/Out Drug And/Or Biologic) (FDA Code: NAE), ...
Aid United International Co., Limited provides medical equipments such as adhesive bandages, ice bags, elastic bandages, oxygen mask, breathing mouthpiece and general surgical scissors. more...
Phone: +86-(21)-64061944
FDA Registration: 3005951403
Products: Ice Bags (FDA Code: KYR), Compression Dressing (FDA Code: MHW), Oval Eye Pads (FDA Code: HMP), Ophthalmic Eye Pad (FDA Code: HMP), Nonresorbable Gauze/sponge for External Use (FDA Code: NAB), Hydrogel Wound Dressing (W/Out Drug And/Or Biologic) (FDA Code: NAE), ...
Aid United International Co., Limited provides medical equipments such as adhesive bandages, ice bags, elastic bandages, oxygen mask, breathing mouthpiece and general surgical scissors. more...
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FDA Code / Regulation: MHW / 880.5075
An elastic bandage is a device consisting of either a long flat strip or a tube of elasticized material that is used to support and compress a part of a patient's body.
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 880.9. The device also is 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, with respect to general requirements concerning records, and 820.198, with respect to complaint files.
