ENT Irrigation Syringe Suppliers
Limit companies to: Worldwide USA
Ultra Surgico | Address: Roras Rd., P.o. Box 272, Sialkot, Punjab 51310, Pakistan
Phone: +92-(52)-3563724
FDA Registration: 9681540
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Disposable Surgical Instrument (FDA Code: KDC), ...
Ultra Surgico manufactures disposable surgical instruments, surgical scissors & forceps, laparoscopic probes, scalpel handles and needle holders. more...
Phone: +92-(52)-3563724
FDA Registration: 9681540
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Disposable Surgical Instrument (FDA Code: KDC), ...
Ultra Surgico manufactures disposable surgical instruments, surgical scissors & forceps, laparoscopic probes, scalpel handles and needle holders. more...
Dentech Surgical Industry | Address: 126-C (a), Fatima Jinnah Road, Small Industrial Estate, Sialkot, Punjab 51340, Pakistan
www.dentech-surgical.com | Send Inquiry | Phone: +92-(52)-3258400
Products: General Surgical Instruments, Common Surgical Instrument, Cardiovascular Surgical Instrument (FDA Code: DWS), Bone Surgery Surgical Instrument, Electrosurgical Instruments for Gynecology, General Manual Obstetric/Gynecologic Instrument (FDA Code: KOH), ...
Dentech Surgical Industry is a manufacturer & exporter of dental, orthodontic and surgical instruments. We are accredited with FDA (USA), ISO 9001/2000 and CE Mark certifications. Our surgical instrum more...
www.dentech-surgical.com | Send Inquiry | Phone: +92-(52)-3258400
Products: General Surgical Instruments, Common Surgical Instrument, Cardiovascular Surgical Instrument (FDA Code: DWS), Bone Surgery Surgical Instrument, Electrosurgical Instruments for Gynecology, General Manual Obstetric/Gynecologic Instrument (FDA Code: KOH), ...
Dentech Surgical Industry is a manufacturer & exporter of dental, orthodontic and surgical instruments. We are accredited with FDA (USA), ISO 9001/2000 and CE Mark certifications. Our surgical instrum more...
Glorious Mercantile Corp. (Pvt) Ltd. | Address: 15 - A, Small Industrial Estate, Sialkot, Punjab, Pakistan
www.glorious-group.com | Send Inquiry | Phone: +92-(52)-3256017, 3255528
FDA Registration: 8040263 Quality: ISO 9001:2000 and ISO 13485:2003 Certified
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
Glorious Mercantile Corp. (Pvt) Ltd. is a manufacturer and exporter of surgical, dental, veterinary, laboratory and all related beauty health care instruments to doctors, hospitals & health service ag more...
www.glorious-group.com | Send Inquiry | Phone: +92-(52)-3256017, 3255528
FDA Registration: 8040263 Quality: ISO 9001:2000 and ISO 13485:2003 Certified
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
Glorious Mercantile Corp. (Pvt) Ltd. is a manufacturer and exporter of surgical, dental, veterinary, laboratory and all related beauty health care instruments to doctors, hospitals & health service ag more...
Nab-Tech Instruments | Address: Small Industries Estate, No. 53-B, Sialkot, punjab, Pakistan
Phone: +092-(432)-552298
FDA Registration: 8044187
Products: Chisel/Osteotome (FDA Code: KDG), Orthopedic Osteotome (FDA Code: HWM), Pinwheel (FDA Code: GWY), External Pelvimeter (FDA Code: HER), Hemostats (FDA Code: HRQ), Orthopedic Needle Holder (FDA Code: HXK), ...
Nab-Tech Instruments is a provider of carvers, chisels, clamps, dilators, probes, elevators and forceps. We also offer needle holders, hemostats, pelvimeters, pliers, scissors and percussors. more...
Phone: +092-(432)-552298
FDA Registration: 8044187
Products: Chisel/Osteotome (FDA Code: KDG), Orthopedic Osteotome (FDA Code: HWM), Pinwheel (FDA Code: GWY), External Pelvimeter (FDA Code: HER), Hemostats (FDA Code: HRQ), Orthopedic Needle Holder (FDA Code: HXK), ...
Nab-Tech Instruments is a provider of carvers, chisels, clamps, dilators, probes, elevators and forceps. We also offer needle holders, hemostats, pelvimeters, pliers, scissors and percussors. 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...
The Mughal Surgical (Pvt) Ltd | Address: C-95 Industrial Estate, P.O.Box 274, Punjab Province, Sialkot, Punjab 51340, Pakistan
www.mughalsurgical.com | Send Inquiry | Phone: +92-(52)-355-3671
Quality: ISO 9001:2008, ISO 13485:2003, CE Certified
Products: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Episiotomy Scissors (FDA Code: HDK), Flexible Depth Gauge (FDA Code: HTJ), Biopsy Forceps Cover (FDA Code: FFF), Ophthalmic Trocar Cannula (FDA Code: NGY), ...
The Mughal Surgical (Pvt)Ltd provides instruments to surgical, dental, veterinary and beauty care fields. Our surgical products include scalpels, scissors, dressing & tissue forceps, retractors, needl more...
www.mughalsurgical.com | Send Inquiry | Phone: +92-(52)-355-3671
Quality: ISO 9001:2008, ISO 13485:2003, CE Certified
Products: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Episiotomy Scissors (FDA Code: HDK), Flexible Depth Gauge (FDA Code: HTJ), Biopsy Forceps Cover (FDA Code: FFF), Ophthalmic Trocar Cannula (FDA Code: NGY), ...
The Mughal Surgical (Pvt)Ltd provides instruments to surgical, dental, veterinary and beauty care fields. Our surgical products include scalpels, scissors, dressing & tissue forceps, retractors, needl more...
Tinopal Surgical Corporation Pvt Ltd. | Address: Unit No. 1, 55/57-B., Small Industries Estate, Sialkot, Punjab 51311, Pakistan
www.tinopal.com | Send Inquiry | Phone: +92-(52)-3255354, 3255454
FDA Registration: 9611070 Year Established: 1973 Quality: ISO 9001:2000, QSR/cGMP, and CE Mark Certified
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
Tinopal Surgical Corporation Pvt Ltd. specializes in offering surgical instruments. We offer surgical, dental and single use surgical instruments. Our surgical instruments include diagnostic instrumen more...
www.tinopal.com | Send Inquiry | Phone: +92-(52)-3255354, 3255454
FDA Registration: 9611070 Year Established: 1973 Quality: ISO 9001:2000, QSR/cGMP, and CE Mark Certified
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
Tinopal Surgical Corporation Pvt Ltd. specializes in offering surgical instruments. We offer surgical, dental and single use surgical instruments. Our surgical instruments include diagnostic instrumen more...
T.A. Walthem & Company | Address: P.B # 1767, Wazirabad road, Sialkot, Punjab PB 51310, Pakistan
www.tawalthem.com | Send Inquiry | Phone: +92-(52)-3255829
FDA Registration: 3003407244 Employee Count: ~1970 Quality: ISO 9002, ISO 13488, CE Mark Certified
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
T.A. Walthem & Company is a manufacturer and exporter of medical & surgical instruments. Our product line includes eye needle holders, lid retractors, iris forceps, Graefe forceps, Knapp forceps, Chal more...
www.tawalthem.com | Send Inquiry | Phone: +92-(52)-3255829
FDA Registration: 3003407244 Employee Count: ~1970 Quality: ISO 9002, ISO 13488, CE Mark Certified
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
T.A. Walthem & Company is a manufacturer and exporter of medical & surgical instruments. Our product line includes eye needle holders, lid retractors, iris forceps, Graefe forceps, Knapp forceps, Chal more...
K Plus International | Address: 61/22 Tariq Road Cantt, Sialkot, Punjab 51310, Pakistan
Phone: +92-(52)-4269583
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
K Plus International offers medical and surgical instruments. Our products include surgical instrument trays, surgical pliers, medical probes, surgical hammers, surgical orthopedic scissors, mouth gag more...
Phone: +92-(52)-4269583
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
K Plus International offers medical and surgical instruments. Our products include surgical instrument trays, surgical pliers, medical probes, surgical hammers, surgical orthopedic scissors, mouth gag more...
Aemco Z E (Pvt) Ltd | Address: Elahiabad, Wazirabad Road, Silakot, Punjab 51330, Pakistan
Send Inquiry | Phone: +92-(52)-4263222
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
Aemco Z E (Pvt) Ltd is a supplier of cardiac catheterisation equipment, surgical instruments and endoscopes. We offer bone cutting forceps, otoscopes, orthopedic scissors, retractors, needle holders a more...
Send Inquiry | Phone: +92-(52)-4263222
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
Aemco Z E (Pvt) Ltd is a supplier of cardiac catheterisation equipment, surgical instruments and endoscopes. We offer bone cutting forceps, otoscopes, orthopedic scissors, retractors, needle holders a more...
Concise Enterprises | Address: Mualim Para, Kotli Behram, Sialkot 51310, Pakistan
www.concise.com.pk | Send Inquiry | Phone: +92-(432)-270271, 260459
FDA Registration: 3003334541
Products: Stethoscopes, Tissue Forceps, Hammers, General Surgical Instruments, Forceps, Hemostatic, Surgical Instrument (Miscellaneous Medical), ...
Concise Enterprises manufactures surgical, dental, T.C pedicure, veterinary, orthodontics, hollow-wear and wide range of scissors & pliers. Our surgical instruments comprise of diagnostics, anesthesia more...
www.concise.com.pk | Send Inquiry | Phone: +92-(432)-270271, 260459
FDA Registration: 3003334541
Products: Stethoscopes, Tissue Forceps, Hammers, General Surgical Instruments, Forceps, Hemostatic, Surgical Instrument (Miscellaneous Medical), ...
Concise Enterprises manufactures surgical, dental, T.C pedicure, veterinary, orthodontics, hollow-wear and wide range of scissors & pliers. Our surgical instruments comprise of diagnostics, anesthesia more...
Nagashima Medical Instrument Co., Ltd. | Address: 5-24-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
www.nagashima-medical.co.jp | Send Inquiry | Phone: +81-(3)-3812-1271
Products: General ENT Supplies, ENT Syringe (FDA Code: KCP), Ear Syringes Repair Service, Baby Ear Syringe, Electric Ear Syringe, ENT Irrigation Syringe (FDA Code: KCP), ...
Nagashima Medical Instrument Co., Ltd. exports and imports ENT equipment & instruments. Our product line includes cameras for endoscope, camera microscope arm installation, headlights, minute forceps more...
www.nagashima-medical.co.jp | Send Inquiry | Phone: +81-(3)-3812-1271
Products: General ENT Supplies, ENT Syringe (FDA Code: KCP), Ear Syringes Repair Service, Baby Ear Syringe, Electric Ear Syringe, ENT Irrigation Syringe (FDA Code: KCP), ...
Nagashima Medical Instrument Co., Ltd. exports and imports ENT equipment & instruments. Our product line includes cameras for endoscope, camera microscope arm installation, headlights, minute forceps 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...
Soulgenie Health Pathways LLP | Address: B-36, Sector 31, Noida 201303, India 
Phone: +91-(120)-2456137, 2456137
FDA Registration: 3008530452
Products: Enema Supplies, ENT Syringe (FDA Code: KCP), ENT Irrigation Syringe (FDA Code: KCP), Enema Kit (For Cleaning Purpose) (FDA Code: FCE), ...
Soulgenie Health Pathways LLP is a manufacturer, exporter and supplier of yoga products and meditation supplies. Our product line includes stainless steel Neti pots, enema equipment, meditation mala b more...
Phone: +91-(120)-2456137, 2456137
FDA Registration: 3008530452
Products: Enema Supplies, ENT Syringe (FDA Code: KCP), ENT Irrigation Syringe (FDA Code: KCP), Enema Kit (For Cleaning Purpose) (FDA Code: FCE), ...
Soulgenie Health Pathways LLP is a manufacturer, exporter and supplier of yoga products and meditation supplies. Our product line includes stainless steel Neti pots, enema equipment, meditation mala b more...
General Surgical Co., (india) Pvt. Ltd. | Address: G-6 Gee Cee Crescent, 114, Ponamallee High Road, Chennai, Tamil Nadu 60084, India
www.gescoindia.com | Send Inquiry | Phone: +91-(44)-2825 96 02
FDA Registration: 9613926 Quality: ISO 9001:2000 Certified
Products: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Y-Stent Forceps, Guiding Probes, Flexible Depth Gauge (FDA Code: HTJ), ENT Forceps (FDA Code: KAE), ...
General Surgical Co., (india) Pvt. Ltd. is a manufacturer of surgical instruments. We produce medical & surgical disposables, general, ENT, neuro & spinal, orthopedic, gynecology & obstetrics, plastic more...
www.gescoindia.com | Send Inquiry | Phone: +91-(44)-2825 96 02
FDA Registration: 9613926 Quality: ISO 9001:2000 Certified
Products: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Y-Stent Forceps, Guiding Probes, Flexible Depth Gauge (FDA Code: HTJ), ENT Forceps (FDA Code: KAE), ...
General Surgical Co., (india) Pvt. Ltd. is a manufacturer of surgical instruments. We produce medical & surgical disposables, general, ENT, neuro & spinal, orthopedic, gynecology & obstetrics, plastic more...
Wiltec Industries (hk) Limited | Address: 18/F, CCT Telecom Building, 11 Wo Shing Street, Fotan, Shatin, N.T., Hong Kong 
www.wiltechk.com | Send Inquiry | Phone: +86-(852)-2375 4388
FDA Registration: 9681522
Products: Clinical Mercury Thermometers (FDA Code: FLK), Nasal Aspirator, Medicine Spoon, Continuous Electronic Thermometer (FDA Code: FLL), Medicine Dropper, Nail Clipper, ...
Wiltec Industries (hk) Limited manufactures clinical mercury thermometers, continuous electronic thermometer, ENT irrigation syringe, ENT syringe, liquid crystal forehead temperature strip and liquid more...
www.wiltechk.com | Send Inquiry | Phone: +86-(852)-2375 4388
FDA Registration: 9681522
Products: Clinical Mercury Thermometers (FDA Code: FLK), Nasal Aspirator, Medicine Spoon, Continuous Electronic Thermometer (FDA Code: FLL), Medicine Dropper, Nail Clipper, ...
Wiltec Industries (hk) Limited manufactures clinical mercury thermometers, continuous electronic thermometer, ENT irrigation syringe, ENT syringe, liquid crystal forehead temperature strip and liquid more...
Mayfair Medical Supplies Ltd. | Address: 16/f., Rm 1605-1611, 238 Nathan Road, Kowloon, Hong Kong
www.mayfairmed.com | Send Inquiry | Phone: +852-(0)-2721-0291, 3156-1166
FDA Registration: 8040251 Quality: ISO 9001:2000 & ISO 13485:2003 Certified
Products: ENT Syringe (FDA Code: KCP), ENT Irrigation Syringe (FDA Code: KCP), Surgical Hammer (FDA Code: FZY), Single Use Acupuncture Needle (FDA Code: MQX), Pressure Applying Device (FDA Code: KNM), Electric Therapeutic Massager (FDA Code: ISA), ...
Mayfair Medical Supplies Ltd. is a supplier of home healthcare products. We specialize in supplying concentrated powdered herbs, acupuncture & moxibustion products, physiotherapy & home healthcare dev more...
www.mayfairmed.com | Send Inquiry | Phone: +852-(0)-2721-0291, 3156-1166
FDA Registration: 8040251 Quality: ISO 9001:2000 & ISO 13485:2003 Certified
Products: ENT Syringe (FDA Code: KCP), ENT Irrigation Syringe (FDA Code: KCP), Surgical Hammer (FDA Code: FZY), Single Use Acupuncture Needle (FDA Code: MQX), Pressure Applying Device (FDA Code: KNM), Electric Therapeutic Massager (FDA Code: ISA), ...
Mayfair Medical Supplies Ltd. is a supplier of home healthcare products. We specialize in supplying concentrated powdered herbs, acupuncture & moxibustion products, physiotherapy & home healthcare dev more...
Technic Star Ltd | Address: Rm. 1013, Hung To Rd., No. 1, Kwun Tong, Hong Kong
Products: ENT Syringe (FDA Code: KCP), ENT Irrigation Syringe (FDA Code: KCP), Liquid Medication Dispenser (FDA Code: KYX), Non-Powered Breast Pump (FDA Code: HGY), Reusable Hot /Cold Pack (FDA Code: IME), ...
Technic Star Ltd offers various medical products such as non-powered breast pumps, ENT syringes and liquid medication dispensers. more...
Products: ENT Syringe (FDA Code: KCP), ENT Irrigation Syringe (FDA Code: KCP), Liquid Medication Dispenser (FDA Code: KYX), Non-Powered Breast Pump (FDA Code: HGY), Reusable Hot /Cold Pack (FDA Code: IME), ...
Technic Star Ltd offers various medical products such as non-powered breast pumps, ENT syringes and liquid medication dispensers. more...
Eurosurgical Germany Ltd. | Address: Forum Landsberger Allee, Landsberger, Allee 117a-9og, Berlin 10407, Germany 
Phone: +49-(30)-930-24115
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
Eurosurgical Germany Ltd. manufactures medical surgical products. Our products include calipers, curettes, disposable surgical instrument kits, ENT irrigation syringes, plastic surgery surgical gouges more...
Phone: +49-(30)-930-24115
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
Eurosurgical Germany Ltd. manufactures medical surgical products. Our products include calipers, curettes, disposable surgical instrument kits, ENT irrigation syringes, plastic surgery surgical gouges more...
Baur Und Haselbarth-Chirurg Gmbh | Address: Sauerbruchstr. 7, Ellerau 25479, Germany
www.bh-chirurg.de | Phone: +49-(4106)-80890
FDA Registration: 9610621
Products: Obstetrical Forceps (FDA Code: HDA), ENT Syringe (FDA Code: KCP), Ear Syringes Repair Service, Baby Ear Syringe, Electric Ear Syringe, ENT Irrigation Syringe (FDA Code: KCP), ...
Baur Und Haselbarth-Chirurg GmbH is a manufacturer of surgical instruments. We manufacture a broad variety of surgical instruments including aspiration & suction instruments, atomizers, ear specula, g more...
www.bh-chirurg.de | Phone: +49-(4106)-80890
FDA Registration: 9610621
Products: Obstetrical Forceps (FDA Code: HDA), ENT Syringe (FDA Code: KCP), Ear Syringes Repair Service, Baby Ear Syringe, Electric Ear Syringe, ENT Irrigation Syringe (FDA Code: KCP), ...
Baur Und Haselbarth-Chirurg GmbH is a manufacturer of surgical instruments. We manufacture a broad variety of surgical instruments including aspiration & suction instruments, atomizers, ear specula, g more...
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FDA Code / Regulation: KCP / 874.5220
An ear, nose, and throat drug administration device is one of a group of ear, nose, and throat devices intended specifically to administer medicinal substances to treat ear, nose, and throat disorders. These instruments include the powder blower, dropper, ear wick, manual nebulizer pump, and nasal inhaler.
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. If the device is not labeled or otherwise represented as sterile, it 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.
