Nasal Splints Suppliers
Limit companies to: Worldwide USA
Boston Medical Products, Inc. | Address: 117 Flanders Road, Westborough, Massachusetts 01581-1042, USA 
www.bosmed.com | Send Inquiry | Phone: +1-(508)-898-9300, 800-433-2674
FDA Registration: 1219795 Year Established: 1980 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Packings, Laryngectomy Tube (FDA Code: KAC), Tracheostomy Tubes, Nasal Splints (FDA Code: EPP), Ear Wick (FDA Code: KCN), Instrument Wipe, ...
Boston Medical Products, Inc. specializes in ENT surgical & respiratory products. We offer otology, rhinology, laryngeal & esophageal, throplasty, pulmonolgy, and Safe-T-Tubes™ airway management more...
www.bosmed.com | Send Inquiry | Phone: +1-(508)-898-9300, 800-433-2674
FDA Registration: 1219795 Year Established: 1980 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Packings, Laryngectomy Tube (FDA Code: KAC), Tracheostomy Tubes, Nasal Splints (FDA Code: EPP), Ear Wick (FDA Code: KCN), Instrument Wipe, ...
Boston Medical Products, Inc. specializes in ENT surgical & respiratory products. We offer otology, rhinology, laryngeal & esophageal, throplasty, pulmonolgy, and Safe-T-Tubes™ airway management more...
Micromedics, Inc. | Address: 1270 Eagan Industrial Rd., St. Paul, Minnesota 55121-1385, USA
www.micromedics.com | Send Inquiry | Phone: +1-(651)-452-1977
FDA Registration: 2183425 Year Established: 1982 Annual Revenues: USD 5-10 Million Employee Count: ~70 Quality: ISO 9001,CE Certified
Products: Arthroscopy Instruments, Ear Implants, Ear Popper, Endoscopes Tray, Ear Speculum (FDA Code: EPY), Applicator, ...
Micromedics, Inc. manufactures, develops, and markets various proprietary medical products. Our product list comprises of implants & instruments for ear, nose & throat (ENT) surgery, products for orga more...
www.micromedics.com | Send Inquiry | Phone: +1-(651)-452-1977
FDA Registration: 2183425 Year Established: 1982 Annual Revenues: USD 5-10 Million Employee Count: ~70 Quality: ISO 9001,CE Certified
Products: Arthroscopy Instruments, Ear Implants, Ear Popper, Endoscopes Tray, Ear Speculum (FDA Code: EPY), Applicator, ...
Micromedics, Inc. manufactures, develops, and markets various proprietary medical products. Our product list comprises of implants & instruments for ear, nose & throat (ENT) surgery, products for orga more...
Wfr/aquaplast Corporation | Address: 30 Lawlins Park, Wyckoff, New Jersey 07481, USA
www.nasalsplint.com | Send Inquiry | Phone: +1-(202)-891 1042
Annual Revenues: < USD 1 Million Quality: CE Certified
Products: Cosmetic Surgery, Nasal Prosthetics, Cosmetic Pharmaceuticals, Wound Dressings, Internal Nasal Splints, External Nasal Splints, Fluroplastic Nasal Splint, Nasal Splint Kits, ...
Wfr/aquaplast Corporation produces and distributes low temperature thermoplastics for use in medical & theatrical applications. Our radiation therapy patient immobilization products include moldcare c more...
www.nasalsplint.com | Send Inquiry | Phone: +1-(202)-891 1042
Annual Revenues: < USD 1 Million Quality: CE Certified
Products: Cosmetic Surgery, Nasal Prosthetics, Cosmetic Pharmaceuticals, Wound Dressings, Internal Nasal Splints, External Nasal Splints, Fluroplastic Nasal Splint, Nasal Splint Kits, ...
Wfr/aquaplast Corporation produces and distributes low temperature thermoplastics for use in medical & theatrical applications. Our radiation therapy patient immobilization products include moldcare c more...
Larson Medical Products, Inc. | Address: 2844 Banwick Rd., Columbus, Ohio 43232, USA
www.larsonproducts.com | Send Inquiry | Phone: +1-(614)-235-9100
FDA Registration: 1530561 Year Established: 1989
Products: Splints, Thermoplastic Splints, Nasal Splints (FDA Code: EPP), Hand Splint and Component (FDA Code: ILH), Medical Linear Accelerator (FDA Code: IYE), Radiographic Head Holder (FDA Code: IWY), ...
Larson Medical Products, Inc. deals with the designing, manufacturing and marketing of low-temperature thermoplastics for patient stabilization. Our product list comprises of immobilization masks and more...
www.larsonproducts.com | Send Inquiry | Phone: +1-(614)-235-9100
FDA Registration: 1530561 Year Established: 1989
Products: Splints, Thermoplastic Splints, Nasal Splints (FDA Code: EPP), Hand Splint and Component (FDA Code: ILH), Medical Linear Accelerator (FDA Code: IYE), Radiographic Head Holder (FDA Code: IWY), ...
Larson Medical Products, Inc. deals with the designing, manufacturing and marketing of low-temperature thermoplastics for patient stabilization. Our product list comprises of immobilization masks and more...
WFR/Aquaplast Corp. | Address: 440 Church Road, Avondale, Pennsylvania 19311, USA
www.q-fix.com | Send Inquiry | Phone: +1-(610)-268-0585
FDA Registration: 2247992
Products: Surgery Tables Repair Service, Radiotherapy Equipment, Medical Diagnostic Imaging, Powered Radiation Therapy Couch (FDA Code: JAI), Radiologic Table (FDA Code: KXJ), Skin Graft Guard (FDA Code: LZM), ...
WFR/Aquaplast Corporation specializes in radiotherapy patient positioning and immobilization products. Our AccuFix™ Cantilever Board™ Featherline Edition is a patented head and neck device more...
www.q-fix.com | Send Inquiry | Phone: +1-(610)-268-0585
FDA Registration: 2247992
Products: Surgery Tables Repair Service, Radiotherapy Equipment, Medical Diagnostic Imaging, Powered Radiation Therapy Couch (FDA Code: JAI), Radiologic Table (FDA Code: KXJ), Skin Graft Guard (FDA Code: LZM), ...
WFR/Aquaplast Corporation specializes in radiotherapy patient positioning and immobilization products. Our AccuFix™ Cantilever Board™ Featherline Edition is a patented head and neck device more...
Surgical Technology Laboratories Inc. | Address: 610 Clemson Rd., Columbia, South Carolina 29229, USA
Phone: +1-(803)-462-1714
FDA Registration: 1825527
Products: Nasal Splints (FDA Code: EPP), Internal Nasal Splints, External Nasal Splints, Fluroplastic Nasal Splint, Padded Aluminium External Nasal Splint, Nasal Splint Kits, ...
Surgical Technology Laboratories Inc. is a manufacturer of various sizes of nasal splints. We provide internal chin prosthesis, internal nasal splints, internal nose prosthesis and external nasal spli more...
Phone: +1-(803)-462-1714
FDA Registration: 1825527
Products: Nasal Splints (FDA Code: EPP), Internal Nasal Splints, External Nasal Splints, Fluroplastic Nasal Splint, Padded Aluminium External Nasal Splint, Nasal Splint Kits, ...
Surgical Technology Laboratories Inc. is a manufacturer of various sizes of nasal splints. We provide internal chin prosthesis, internal nasal splints, internal nose prosthesis and external nasal spli more...
Bausch & Lomb Inc. | Address: 8507 Pelham Rd., Greenville, South Carolina 29615-9598, USA
Phone: +1-(585)-338-6000
FDA Registration: 1032500
Products: Contact Lens (FDA Code: HQD), Contact Lens Case, Container (FDA Code: LRX), ENT Forceps (FDA Code: KAE), Soft Lens Accessories (FDA Code: LPN), Contact Extended Wear Lens (FDA Code: MWL), Contact Lens (Disposable) (FDA Code: MVN), ...
Bausch & Lomb Inc. specializes in offering contact lens and contact lens care products. more...
Phone: +1-(585)-338-6000
FDA Registration: 1032500
Products: Contact Lens (FDA Code: HQD), Contact Lens Case, Container (FDA Code: LRX), ENT Forceps (FDA Code: KAE), Soft Lens Accessories (FDA Code: LPN), Contact Extended Wear Lens (FDA Code: MWL), Contact Lens (Disposable) (FDA Code: MVN), ...
Bausch & Lomb Inc. specializes in offering contact lens and contact lens care products. more...
Hartmann-Conco Inc. | Address: 481 Lakeshore Pkwy., Rock Hill, South Carolina 29730-4205, USA
www.hartmann-conco.com | Send Inquiry | Phone: +1-(803)-325-7600, 800-243-2294
FDA Registration: 1218946 Year Established: 2001 Annual Revenues: USD 25-50 Million Employee Count: ~90 Quality: CE Certified
Products: Adhesive Bandages (FDA Code: KGX), Adhesive Elastic Bandage Tape, Adhesive Bandage Strip, Adhesive Tape Patches, Adhesive Gauze Bandage, Adhesive Tape, ...
Hartmann-Conco Inc. develops and markets a complete range of high-performance product solutions in the areas of incontinence, compression and wound management. We provide high quality bandages, tradit more...
www.hartmann-conco.com | Send Inquiry | Phone: +1-(803)-325-7600, 800-243-2294
FDA Registration: 1218946 Year Established: 2001 Annual Revenues: USD 25-50 Million Employee Count: ~90 Quality: CE Certified
Products: Adhesive Bandages (FDA Code: KGX), Adhesive Elastic Bandage Tape, Adhesive Bandage Strip, Adhesive Tape Patches, Adhesive Gauze Bandage, Adhesive Tape, ...
Hartmann-Conco Inc. develops and markets a complete range of high-performance product solutions in the areas of incontinence, compression and wound management. We provide high quality bandages, tradit more...
Gyrus ENT | Address: 2925 Appling Rd, Bartlett, Tennessee 38133, USA
www.retroxhearing.com | Phone: +1-(800)-2623540
FDA Registration: 1037007
Products: Video Otoscopes, Digital Hearing Aids, Surgical Cochlear Implant (FDA Code: MCM), BTE Hearing Aids, Canal Hearing Aids, Industrial, & Specialty Cases, ...
Gyrus ENT deals with otology, sinus and rhinology fields. We offer otology implants, microsurgical instruments, powered dissectors and biomaterials for sinus surgery. Our retrox, a hearing system is d more...
www.retroxhearing.com | Phone: +1-(800)-2623540
FDA Registration: 1037007
Products: Video Otoscopes, Digital Hearing Aids, Surgical Cochlear Implant (FDA Code: MCM), BTE Hearing Aids, Canal Hearing Aids, Industrial, & Specialty Cases, ...
Gyrus ENT deals with otology, sinus and rhinology fields. We offer otology implants, microsurgical instruments, powered dissectors and biomaterials for sinus surgery. Our retrox, a hearing system is d more...
Mesa, Inc. | Address: 9807 Fredericksburg Rd., San Antonio, Texas 78240, USA
www.mesaone.com | Phone: +1-(210)-699-6911, 800-383-6437
Products: Ankle Braces, Ankle and Foot Braces, Ankle Surgical Wound Wrap, Abdominal Binders (FDA Code: FSD), Acromioclavicular Splint, Ankle Support, ...
Mesa, Inc. is a manufacturer of orthopedic soft goods, patient slings and industrial supports. We also specialize in the orthopedic and medical fields. Our product line includes elastic ankle support, more...
www.mesaone.com | Phone: +1-(210)-699-6911, 800-383-6437
Products: Ankle Braces, Ankle and Foot Braces, Ankle Surgical Wound Wrap, Abdominal Binders (FDA Code: FSD), Acromioclavicular Splint, Ankle Support, ...
Mesa, Inc. is a manufacturer of orthopedic soft goods, patient slings and industrial supports. We also specialize in the orthopedic and medical fields. Our product line includes elastic ankle support, more...
Mueller Sports Medicine, Inc. | Address: One Quench Drive, Prairie du Sac, Wisconsin 53578, USA
www.muellersportsmed.com | Send Inquiry | Phone: +1-(608)-643-8530
FDA Registration: 2110420 Year Established: 1961 Annual Revenues: USD 50-100 Million Employee Count: ~120 Quality: ISO, CE Certified
Products: Scissors, Adhesive Elastic, Adhesive Strips & Patches, Analgesics, Anesthetics, Athletic Cloth, ...
Mueller Sports Medicine, Inc. manufactures products for athletes worldwide. Our product line includes analgesics, cold & hot therapy, exercise & fitness, foot care, grip enhancers, mouth guards, sungl more...
www.muellersportsmed.com | Send Inquiry | Phone: +1-(608)-643-8530
FDA Registration: 2110420 Year Established: 1961 Annual Revenues: USD 50-100 Million Employee Count: ~120 Quality: ISO, CE Certified
Products: Scissors, Adhesive Elastic, Adhesive Strips & Patches, Analgesics, Anesthetics, Athletic Cloth, ...
Mueller Sports Medicine, Inc. manufactures products for athletes worldwide. Our product line includes analgesics, cold & hot therapy, exercise & fitness, foot care, grip enhancers, mouth guards, sungl more...
Asian Marketing Co. | Address: G-23, Palika Place, Panchkuian Road, Next To R. K. Ashram Metro Station, New Delhi, Delhi 110001, India 
Send Inquiry | Phone: +91-(11)-23743954
Products: Nasal Splints (FDA Code: EPP), Internal Nasal Splints, External Nasal Splints, Nasal Septal Splint, Nasal Splint Kits, External Nasal Splint Prosthesis, ...
Asian Marketing Co. specializes in providing middle ear micro surgical implant prosthesis. We also offer ear implants, malleus replacement prostheses, and internal nasal septal splints. more...
Send Inquiry | Phone: +91-(11)-23743954
Products: Nasal Splints (FDA Code: EPP), Internal Nasal Splints, External Nasal Splints, Nasal Septal Splint, Nasal Splint Kits, External Nasal Splint Prosthesis, ...
Asian Marketing Co. specializes in providing middle ear micro surgical implant prosthesis. We also offer ear implants, malleus replacement prostheses, and internal nasal septal splints. more...
Network Medical Products, Ltd. | Address: The Coach House, Phoenix, Business Centre, Ripon, North Yorkshire HG4 1NS, United Kingdom 
www.networkmedical.co.uk | Send Inquiry | Phone: +44-(17)-65609555
FDA Registration: 3001967056
Products: Ear Wick (FDA Code: KCN), Ophthalmic Forceps (FDA Code: HNR), General Surgical Manual Instrument (FDA Code: MDM), Corneo-Scleral Punch (FDA Code: HNJ), Epistaxis Balloon (FDA Code: EMX), Intranasal Septal Splint (FDA Code: LYA), ...
Network Medical Products, Ltd specializes in the production of ENT and ophthalmic products. Our ENT products include nasal packing, ear products, instrument wipes, headbands, stapes pistons, nasal spl more...
www.networkmedical.co.uk | Send Inquiry | Phone: +44-(17)-65609555
FDA Registration: 3001967056
Products: Ear Wick (FDA Code: KCN), Ophthalmic Forceps (FDA Code: HNR), General Surgical Manual Instrument (FDA Code: MDM), Corneo-Scleral Punch (FDA Code: HNJ), Epistaxis Balloon (FDA Code: EMX), Intranasal Septal Splint (FDA Code: LYA), ...
Network Medical Products, Ltd specializes in the production of ENT and ophthalmic products. Our ENT products include nasal packing, ear products, instrument wipes, headbands, stapes pistons, nasal spl more...
Medical Devices Technology International Limited | Address: The Kace Building, Victoria Passage, Wolverhampton WV1 4LG, United Kingdom
www.mdti.co.uk | Send Inquiry | Phone: +44-(1902)-778380
FDA Registration: 3005554528
Products: Nasal Splints (FDA Code: EPP), Uroflowmeter (FDA Code: EXY), Infusion Stand (FDA Code: FOX), Fixed Size Cervical Dilator (FDA Code: HDQ), Non-Measuring Exerciser (FDA Code: ION), ...
Medical Devices Technology International Limited provides medical equipments. We offer rehabilitation, intravenous, male health and female health products. Our rehabilitation products are Physio-maste more...
www.mdti.co.uk | Send Inquiry | Phone: +44-(1902)-778380
FDA Registration: 3005554528
Products: Nasal Splints (FDA Code: EPP), Uroflowmeter (FDA Code: EXY), Infusion Stand (FDA Code: FOX), Fixed Size Cervical Dilator (FDA Code: HDQ), Non-Measuring Exerciser (FDA Code: ION), ...
Medical Devices Technology International Limited provides medical equipments. We offer rehabilitation, intravenous, male health and female health products. Our rehabilitation products are Physio-maste more...
Selam Medikal Ltd. | Address: Barbaros Mah. Mütevelli Çeşme Cad. Mustafa Pehlivan Sok. No:3/2, Üsküdar, İSTANBUL, Turkey 
www.selammedikal.com.tr | Send Inquiry | Phone: +90-(216)-3914718
Products: Middle Ear Implants, Ear Implants, Titanium Middle Ear Implants, Nasal Splints (FDA Code: EPP), Internal Nasal Splints, Nerve Locators, ...
Selam Medikal Ltd. is a supplier of ENT equipment. Our products include neuro - pulse nerve locators, titanium middle ear implants, nasal & ear pack, silicone nasal splint, and internal nasal splint. more...
www.selammedikal.com.tr | Send Inquiry | Phone: +90-(216)-3914718
Products: Middle Ear Implants, Ear Implants, Titanium Middle Ear Implants, Nasal Splints (FDA Code: EPP), Internal Nasal Splints, Nerve Locators, ...
Selam Medikal Ltd. is a supplier of ENT equipment. Our products include neuro - pulse nerve locators, titanium middle ear implants, nasal & ear pack, silicone nasal splint, and internal nasal splint. more...
Combined Instruments (Pvt.), Ltd. | Address: 13-A Model Town, Ugoki, Sailkot, Pakistan
Phone: +92-(432)-510243
Products: Adenoid Punches (FDA Code: KBS), Adult Tongue Depressor (FDA Code: FMA), Adjustable Frequency Tuning Fork, A.V.Fistula Needle Set, A.V. Fistula Needle, Acoustical Fetal Holograph (FDA Code: HHX), ...
Combined Instruments (Pvt.), Ltd. is a manufacturer and exporter of general surgery instruments. Our products include cotton applicators, scalpel blades, depth gauge, ear speculum holders, biopsy & su more...
Phone: +92-(432)-510243
Products: Adenoid Punches (FDA Code: KBS), Adult Tongue Depressor (FDA Code: FMA), Adjustable Frequency Tuning Fork, A.V.Fistula Needle Set, A.V. Fistula Needle, Acoustical Fetal Holograph (FDA Code: HHX), ...
Combined Instruments (Pvt.), Ltd. is a manufacturer and exporter of general surgery instruments. Our products include cotton applicators, scalpel blades, depth gauge, ear speculum holders, biopsy & su more...
Towne Brothers (Pvt) Ltd. | Address: 56-56 B ,Industrial Estate, P .O. Box # 108, Sialkot, Punjab 51340, Pakistan
www.towne-pk.com | Send Inquiry | Phone: +92-(52)-553231, 555334
FDA Registration: 9613083 Year Established: 1940 Quality: ISO 9001:2000 and ISO 13485:2003 Certified
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Scalpel Handle (FDA Code: GDZ), Measuring Gauge (FDA Code: JYJ), General & Plastic Surgery Forceps (FDA Code: GEN), General & Plastic Surgery Surgical Spatula (FDA Code: GAF), Surgical Knife (FDA Code: EMF), ...
Towne Brothers (Pvt) Ltd. is a manufacturer of surgical, dental, orthodontic and ophthalmic instruments. Our surgical instruments include anesthesia instruments, dissecting & ligature forceps, cardiov more...
www.towne-pk.com | Send Inquiry | Phone: +92-(52)-553231, 555334
FDA Registration: 9613083 Year Established: 1940 Quality: ISO 9001:2000 and ISO 13485:2003 Certified
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Scalpel Handle (FDA Code: GDZ), Measuring Gauge (FDA Code: JYJ), General & Plastic Surgery Forceps (FDA Code: GEN), General & Plastic Surgery Surgical Spatula (FDA Code: GAF), Surgical Knife (FDA Code: EMF), ...
Towne Brothers (Pvt) Ltd. is a manufacturer of surgical, dental, orthodontic and ophthalmic instruments. Our surgical instruments include anesthesia instruments, dissecting & ligature forceps, cardiov more...
Adept Medical Ltd | Address: 2 Mcdonald Street, Morningside, Auckland 1003, New Zealand
www.distributors.adeptmedical.co.nz | Send Inquiry | Phone: +64-(9)-815 5285
FDA Registration: 3006098219
Products: Ear Curette (FDA Code: JYG), ENT Forceps (FDA Code: KAE), Ear Speculum (FDA Code: EPY), Ear Suction Tube (FDA Code: JZF), Intranasal Septal Splint (FDA Code: LYA), Myringotomy Knife (FDA Code: JYP), ...
Adept Medical Ltd deals with ENT products. Our ENT product line comprises of otological ventilation tubes, sterile otology kits and instruments. We also offer products for disposable ear care & rhinol more...
www.distributors.adeptmedical.co.nz | Send Inquiry | Phone: +64-(9)-815 5285
FDA Registration: 3006098219
Products: Ear Curette (FDA Code: JYG), ENT Forceps (FDA Code: KAE), Ear Speculum (FDA Code: EPY), Ear Suction Tube (FDA Code: JZF), Intranasal Septal Splint (FDA Code: LYA), Myringotomy Knife (FDA Code: JYP), ...
Adept Medical Ltd deals with ENT products. Our ENT product line comprises of otological ventilation tubes, sterile otology kits and instruments. We also offer products for disposable ear care & rhinol more...
Hans Biomed Corp. | Address: 8th Fl., Sk Building , 16-4 Sungsudong-1 G, Sungdong-Gu 133-110, Korea, Republic Of 
www.hansbiomed.com | Send Inquiry | Phone: +82-(2)-466-2266
FDA Registration: 3003828812
Products: Scar Treatment Kits, Herbal Aromatherapy Heating Cooling Pack, Nasal Splints (FDA Code: EPP), Breast Implants, Silicone Gel Sheets, Surgical Wire (FDA Code: LRN), ...
Hans Biomed Corp. deals with human tissue engineering. We offer products for plastic surgery, cosmetics, dentistry, orthopedics and burns. Our plastic surgery products include SureDerm ™ and Sca more...
www.hansbiomed.com | Send Inquiry | Phone: +82-(2)-466-2266
FDA Registration: 3003828812
Products: Scar Treatment Kits, Herbal Aromatherapy Heating Cooling Pack, Nasal Splints (FDA Code: EPP), Breast Implants, Silicone Gel Sheets, Surgical Wire (FDA Code: LRN), ...
Hans Biomed Corp. deals with human tissue engineering. We offer products for plastic surgery, cosmetics, dentistry, orthopedics and burns. Our plastic surgery products include SureDerm ™ and Sca more...
Olympus Imaging Corporation | Address: 3-1 Nishi-Shinjuku 2-chome, Shinjuku-ku, Tokyo 163-0914, Japan
www.olympus.co.jp | Phone: +81-(3)-3340-2111
FDA Registration: 8010047
Products: Flexible Endoscope Accessory Hanger, Flexible Endoscopes (FDA Code: GCQ), Flexible Endoscope Repair Parts - Biopsy Channels, Flexible Endoscope Repair Parts - Insertion Tubes, Flexible/Rigid Bronchoscope (FDA Code: EOQ), Non Rigid Laryngoscope (FDA Code: CAL), ...
Olympus Imaging Corporation specializes in medical endoscopes and surgical products,artificial bone replacement material and dental products. We also deal with microscopes and the medical information more...
www.olympus.co.jp | Phone: +81-(3)-3340-2111
FDA Registration: 8010047
Products: Flexible Endoscope Accessory Hanger, Flexible Endoscopes (FDA Code: GCQ), Flexible Endoscope Repair Parts - Biopsy Channels, Flexible Endoscope Repair Parts - Insertion Tubes, Flexible/Rigid Bronchoscope (FDA Code: EOQ), Non Rigid Laryngoscope (FDA Code: CAL), ...
Olympus Imaging Corporation specializes in medical endoscopes and surgical products,artificial bone replacement material and dental products. We also deal with microscopes and the medical information more...
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FDA Code / Regulation: EPP / 874.5800
An external nasal splint is a rigid or partially rigid device intended for use externally for immobilization of parts of the nose.
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 874.9.
