ENT Irrigation Syringe Suppliers
Limit companies to: Worldwide USA
Shalatco (Pvt) Ltd. | Address: 68A-69A Tipu Road Small Industrial Estate, Sialkot, PK-PB 51310, Pakistan
shalatcoltd.com | Send Inquiry | Phone: +92-(52)-3555267
Products: Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Scalpel Handle (FDA Code: GDZ), General & Plastic Surgery Surgical Spatula (FDA Code: GAF), Surgical Hammer (FDA Code: FZY), Surgical Pliers (FDA Code: HTC), ...
Shalatco (Pvt) Ltd. is a supplier of dental and surgical instruments. We are an ISO 9001:2000 and ISO 13485:2003 certified company. Our products include surgical scissors, calipers, curettes, knives, more...
shalatcoltd.com | Send Inquiry | Phone: +92-(52)-3555267
Products: Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Scalpel Handle (FDA Code: GDZ), General & Plastic Surgery Surgical Spatula (FDA Code: GAF), Surgical Hammer (FDA Code: FZY), Surgical Pliers (FDA Code: HTC), ...
Shalatco (Pvt) Ltd. is a supplier of dental and surgical instruments. We are an ISO 9001:2000 and ISO 13485:2003 certified company. Our products include surgical scissors, calipers, curettes, knives, more...
Oraltech Instruments (Pvt) Ltd. | Address: Po Box #1600, Khan Villa, Cheema St Model Town, Sialkot, PK-PB 51310, Pakistan
Send Inquiry | Phone: +92-(52)-3555242
Quality: ISO 9001:2000 Certified
Products: Forceps (FDA Code: HTD), Rigid Laryngoscope (FDA Code: CCW), General & Plastic Surgery Surgical Spatula (FDA Code: GAF), Surgical Punch (FDA Code: LRY), Surgical Pliers (FDA Code: HTC), ENT Mirror (FDA Code: KAI), ...
Oraltech Instruments (pvt) Ltd. is a manufacturer of dental and surgical instruments. Our product line includes extracting forceps, root elevators, orthodontic pliers, filling instruments, bone curett more...
Send Inquiry | Phone: +92-(52)-3555242
Quality: ISO 9001:2000 Certified
Products: Forceps (FDA Code: HTD), Rigid Laryngoscope (FDA Code: CCW), General & Plastic Surgery Surgical Spatula (FDA Code: GAF), Surgical Punch (FDA Code: LRY), Surgical Pliers (FDA Code: HTC), ENT Mirror (FDA Code: KAI), ...
Oraltech Instruments (pvt) Ltd. is a manufacturer of dental and surgical instruments. Our product line includes extracting forceps, root elevators, orthodontic pliers, filling instruments, bone curett more...
Pintech Instruments | Address: 291 Mohallah East , Bhopalwala, Teh Sambrial, Sialkot, PK-PB 51310, Pakistan
Products: Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Scalpel Handle (FDA Code: GDZ), General & Plastic Surgery Surgical Spatula (FDA Code: GAF), Surgical Hammer (FDA Code: FZY), Surgical Pliers (FDA Code: HTC), ...
Pintech Instruments specializes in offering dental and measuring instruments. We provide filling instruments, crown removers, matrix retainers, head mirrors, articulators, dental & cartridge syringes more...
Products: Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Scalpel Handle (FDA Code: GDZ), General & Plastic Surgery Surgical Spatula (FDA Code: GAF), Surgical Hammer (FDA Code: FZY), Surgical Pliers (FDA Code: HTC), ...
Pintech Instruments specializes in offering dental and measuring instruments. We provide filling instruments, crown removers, matrix retainers, head mirrors, articulators, dental & cartridge syringes more...
Raiz & Sajjad Surgical (PVT) LTD. | Address: Raiz And Sajjad Surgical Pvt Ltd Jail Rd, Sialkot, PK-PB 51310, Pakistan
www.raizent.com | Send Inquiry | Phone: +92-(52)-4274284
Products: Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Scalpel Handle (FDA Code: GDZ), General & Plastic Surgery Surgical Spatula (FDA Code: GAF), Surgical Hammer (FDA Code: FZY), Surgical Pliers (FDA Code: HTC), ...
Raiz & Sajjad Surgical (PVT) LTD. provides surgical, dental & veterinary instruments and hospital furniture. Our surgical instruments include diagnostic instruments, scapel holders, general & oprating more...
www.raizent.com | Send Inquiry | Phone: +92-(52)-4274284
Products: Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Scalpel Handle (FDA Code: GDZ), General & Plastic Surgery Surgical Spatula (FDA Code: GAF), Surgical Hammer (FDA Code: FZY), Surgical Pliers (FDA Code: HTC), ...
Raiz & Sajjad Surgical (PVT) LTD. provides surgical, dental & veterinary instruments and hospital furniture. Our surgical instruments include diagnostic instruments, scapel holders, general & oprating more...
Micro Engineering Co. | Address: Muzaffar Pur, Ugoki Road, Sialkot, PK-PB 51310, Pakistan
www.micromanicure.com | Send Inquiry | Phone: +92-(52)-3563928
Products: General & Plastic Surgery Mirror (FDA Code: FTX), General Surgical Scissors (FDA Code: LRW), Surgical Cutter (FDA Code: FZT), Tweezer Type High-Frequency Epilator (FDA Code: KCX), Manual Cast Application and Removal Instrument (FDA Code: LGG), Surgical Orthopedic Scissors (FDA Code: HRR), ...
Micro Engineering Co. is a manufacturer of surgical, dental and personal care instruments. Our surgical products include diagnostic, scissors, dissecting & tissue forceps, ligature forceps, suture, re more...
www.micromanicure.com | Send Inquiry | Phone: +92-(52)-3563928
Products: General & Plastic Surgery Mirror (FDA Code: FTX), General Surgical Scissors (FDA Code: LRW), Surgical Cutter (FDA Code: FZT), Tweezer Type High-Frequency Epilator (FDA Code: KCX), Manual Cast Application and Removal Instrument (FDA Code: LGG), Surgical Orthopedic Scissors (FDA Code: HRR), ...
Micro Engineering Co. is a manufacturer of surgical, dental and personal care instruments. Our surgical products include diagnostic, scissors, dissecting & tissue forceps, ligature forceps, suture, re more...
Asuzna Instrument Co. | Address: Off No. 551,Kotli Loharan West, Sialkot, Punjab, Pakistan
www.asuzna.com | Send Inquiry | Phone: +92-(520)-353-531348
FDA Registration: 3006541044
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
Asuzna Instrument Co. manufactures calipers, curettes, disposable surgical instrument kits and ear cannula. We supply ENT irrigation syringes, forceps, gastroenterologic needle holders, general & plas more...
www.asuzna.com | Send Inquiry | Phone: +92-(520)-353-531348
FDA Registration: 3006541044
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
Asuzna Instrument Co. manufactures calipers, curettes, disposable surgical instrument kits and ear cannula. We supply ENT irrigation syringes, forceps, gastroenterologic needle holders, general & plas more...
Afan Surgico | Address: Air Port Road Gohad Pur, Sialkot, Punjab 51310, Pakistan
Send Inquiry | Phone: +92-(52)-4274350
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
Afan Surgico offers forceps, needle holders, pliers, scalers, scissors and speculums. more...
Send Inquiry | Phone: +92-(52)-4274350
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
Afan Surgico offers forceps, needle holders, pliers, scalers, scissors and speculums. more...
A.L.M. Surgicare | Address: 143/c. Fatima Jinnah Rd., Industrial Estate, Sialkot, Punjab, Pakistan
www.almsurgicare.com | Send Inquiry | Phone: +92-(52)-3556039
Quality: IS0 9001:2000 Certified
Products: ENT Syringe (FDA Code: KCP), ENT Irrigation Syringe (FDA Code: KCP), Ear Speculum (FDA Code: EPY), Cuff Spreader (FDA Code: CBG), ENT Probe (FDA Code: KAK), Gastro-Urology Probe and Director (FDA Code: FGM), ...
A.L.M. Surgicare manufactures and exports reusable surgical & dental instruments, chiropody, pedicure & manicure instruments & ranges of tungsten carbide inserted scissors, needle holders & nail & wir more...
www.almsurgicare.com | Send Inquiry | Phone: +92-(52)-3556039
Quality: IS0 9001:2000 Certified
Products: ENT Syringe (FDA Code: KCP), ENT Irrigation Syringe (FDA Code: KCP), Ear Speculum (FDA Code: EPY), Cuff Spreader (FDA Code: CBG), ENT Probe (FDA Code: KAK), Gastro-Urology Probe and Director (FDA Code: FGM), ...
A.L.M. Surgicare manufactures and exports reusable surgical & dental instruments, chiropody, pedicure & manicure instruments & ranges of tungsten carbide inserted scissors, needle holders & nail & wir more...
Imran Brothers Instruments | Address: Chowk Fateh Ghar, Defence Road, Sialkot, Punjab 51310, Pakistan
www.ibroi.com | Phone: +92-(52)-3252345
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
Imran Brothers Instruments offers ENT diagnostic surgical instruments. Our products include forceps, needle holders, otoscope sets, percussion hammers, scalpel handles, scissors, specula, surgical pro more...
www.ibroi.com | Phone: +92-(52)-3252345
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
Imran Brothers Instruments offers ENT diagnostic surgical instruments. Our products include forceps, needle holders, otoscope sets, percussion hammers, scalpel handles, scissors, specula, surgical pro more...
Beauty Teck International | Address: Air Port Road, Gohad Pur, Sialkot, Punjab 51310, Pakistan
www.beauty-teck.com | Send Inquiry | Phone: +92-(52)-4295500
Quality: ISO 9001:2000 Certified
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
Beauty Teck International is a manufacturer of surgical instruments like caliper, ENT syringe, curette, forceps, guiding probes, scalpel handle, surgical knife, surgical hammer, saw, mouth gags and su more...
www.beauty-teck.com | Send Inquiry | Phone: +92-(52)-4295500
Quality: ISO 9001:2000 Certified
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
Beauty Teck International is a manufacturer of surgical instruments like caliper, ENT syringe, curette, forceps, guiding probes, scalpel handle, surgical knife, surgical hammer, saw, mouth gags and su more...
Nadir & Co. | Address: Nadir & Co, Ugoki Road, Opp Small, Industrial Estate, Sialkot, Punjab 51340, Pakistan
www.nadirco.com | Send Inquiry | Phone: +92-(52)-3556741
FDA Registration: 3005897698 Quality: ISO 9001 : 2003 and ISO 13485 : 2003,CE Certified
Products: Bone Rasps (FDA Code: HTR), Bone Mallets (FDA Code: HXL), Bone Clamp (FDA Code: HXD), Disposable Surgical Instrument Kit (FDA Code: KDD), Calipers (FDA Code: KTZ), Curettes (FDA Code: HTF), ...
Nadir & Co. manufactures surgical and diagnostic instruments. Our products line comprises of surgical instruments, dental instruments, orthodontic instruments, laboratory instruments and impression tr more...
www.nadirco.com | Send Inquiry | Phone: +92-(52)-3556741
FDA Registration: 3005897698 Quality: ISO 9001 : 2003 and ISO 13485 : 2003,CE Certified
Products: Bone Rasps (FDA Code: HTR), Bone Mallets (FDA Code: HXL), Bone Clamp (FDA Code: HXD), Disposable Surgical Instrument Kit (FDA Code: KDD), Calipers (FDA Code: KTZ), Curettes (FDA Code: HTF), ...
Nadir & Co. manufactures surgical and diagnostic instruments. Our products line comprises of surgical instruments, dental instruments, orthodontic instruments, laboratory instruments and impression tr more...
Adam Aids Corporation | Address: 14-A Small Industrial Estate, Sialkot, Punjab 51310, Pakistan
www.adamsaid.com | Send Inquiry | Phone: +92-(52)-3563425/26
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), ENT Syringe (FDA Code: KCP), ENT Irrigation Syringe (FDA Code: KCP), Calipers (FDA Code: KTZ), Curettes (FDA Code: HTF), ...
Adam Aids Corporation is engaged in the manufacture of surgical instruments, dental instruments, and veterinary products. Our surgical instruments include instruments for diagnostics, bone surgery, ne more...
www.adamsaid.com | Send Inquiry | Phone: +92-(52)-3563425/26
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), ENT Syringe (FDA Code: KCP), ENT Irrigation Syringe (FDA Code: KCP), Calipers (FDA Code: KTZ), Curettes (FDA Code: HTF), ...
Adam Aids Corporation is engaged in the manufacture of surgical instruments, dental instruments, and veterinary products. Our surgical instruments include instruments for diagnostics, bone surgery, ne more...
Falcon Surgical Co (Pvt) Ltd. | Address: Wazirabad Rd., P.O. Box 134, Near Village Golophala Ugoki, Sialkot, Punjab, Pakistan
www.falcondental.com.pk | Send Inquiry | Phone: +92-(52)-3510072
Quality: ISO9001:2000,CE Certified
Products: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Laser Power Probe, Laparoscopic Probes, Guiding Probes, Flexible Depth Gauge (FDA Code: HTJ), ...
Falcon Surgical Co (Pvt) Ltd. is engaged in the production of dental single use instruments, surgical, body care, veterinary, microscopy, scissors and orthognathic instruments. We provide surgical pro more...
www.falcondental.com.pk | Send Inquiry | Phone: +92-(52)-3510072
Quality: ISO9001:2000,CE Certified
Products: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Laser Power Probe, Laparoscopic Probes, Guiding Probes, Flexible Depth Gauge (FDA Code: HTJ), ...
Falcon Surgical Co (Pvt) Ltd. is engaged in the production of dental single use instruments, surgical, body care, veterinary, microscopy, scissors and orthognathic instruments. We provide surgical pro more...
Seasoned Surgical Products | Address: Daska Road, Addah, Near Church, Sialkot, Punjab 51310, Pakistan
www.seasonedsurgical.com | Send Inquiry | Phone: +92-(52)-652-6511
Products: Scissors, Eye Specula & Retractors, Vaginal Specula, Needle Holders & Scissors, Artery Forceps, Tonometer Sterilizer (FDA Code: HKZ), ...
Seasoned Surgical Products manufactures and exports surgical instruments, dental instruments, manicure & pedicure products. Our surgical instruments include bone holding forceps & clamps, bone rongeur more...
www.seasonedsurgical.com | Send Inquiry | Phone: +92-(52)-652-6511
Products: Scissors, Eye Specula & Retractors, Vaginal Specula, Needle Holders & Scissors, Artery Forceps, Tonometer Sterilizer (FDA Code: HKZ), ...
Seasoned Surgical Products manufactures and exports surgical instruments, dental instruments, manicure & pedicure products. Our surgical instruments include bone holding forceps & clamps, bone rongeur more...
Quality Point International | Address: Gohadpur, Airport Road, Sialkot, Punjab, Pakistan
Phone: +92-(432)-264974
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), ENT Syringe (FDA Code: KCP), Ophthalmic Suture Scissors (FDA Code: HNF), General & Plastic Surgery Forceps (FDA Code: GEN), General Surgical Scissors (FDA Code: LRW), ENT Probe (FDA Code: KAK), ...
Quality Point International is a manufacturer of surgical instruments and medicine cups. more...
Phone: +92-(432)-264974
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), ENT Syringe (FDA Code: KCP), Ophthalmic Suture Scissors (FDA Code: HNF), General & Plastic Surgery Forceps (FDA Code: GEN), General Surgical Scissors (FDA Code: LRW), ENT Probe (FDA Code: KAK), ...
Quality Point International is a manufacturer of surgical instruments and medicine cups. more...
Technimen Skillers | Address: Small Indus Estate, Sialkot, Punjab 51340, Pakistan
Phone: +92-(523)-561772
FDA Registration: 3001620590
Products: Mouth Gags (FDA Code: KBN), General & Plastic Surgery Forceps (FDA Code: GEN), General Surgical Scissors (FDA Code: LRW), Surgical Head Hammer (FDA Code: GFB), Disposable Medical Scissors (FDA Code: JOK), Ophthalmic Headband Mirror (FDA Code: HKF), ...
Technimen Skillers is a manufacturer of air conduction hearing aids, blood collection lancets, general & plastic surgery forceps, ophthalmic headband mirrors, arm slings, ear suction tubes, scalpel ha more...
Phone: +92-(523)-561772
FDA Registration: 3001620590
Products: Mouth Gags (FDA Code: KBN), General & Plastic Surgery Forceps (FDA Code: GEN), General Surgical Scissors (FDA Code: LRW), Surgical Head Hammer (FDA Code: GFB), Disposable Medical Scissors (FDA Code: JOK), Ophthalmic Headband Mirror (FDA Code: HKF), ...
Technimen Skillers is a manufacturer of air conduction hearing aids, blood collection lancets, general & plastic surgery forceps, ophthalmic headband mirrors, arm slings, ear suction tubes, scalpel ha more...
Zain's Medical Image | Address: 5-Kilometer Wazirabad Road Golo Phala, Small Industies Estate, Sialkot, Punjab, Pakistan
www.zainsmedical.com | Send Inquiry | Phone: +92-(52)-357 0726
FDA Registration: 3003877407
Products: General & Plastic Surgery Surgical Gouge (FDA Code: GDH), General Surgical Scissors (FDA Code: LRW), Surgical Hammer (FDA Code: FZY), General Manual Obstetric/Gynecologic Instrument (FDA Code: KOH), Orthopedic Burr (FDA Code: HTT), Surgical Pliers (FDA Code: HTC), ...
Zain's Medical Image is a manufacturer of surgical, dental, manicure, and single use instruments. more...
www.zainsmedical.com | Send Inquiry | Phone: +92-(52)-357 0726
FDA Registration: 3003877407
Products: General & Plastic Surgery Surgical Gouge (FDA Code: GDH), General Surgical Scissors (FDA Code: LRW), Surgical Hammer (FDA Code: FZY), General Manual Obstetric/Gynecologic Instrument (FDA Code: KOH), Orthopedic Burr (FDA Code: HTT), Surgical Pliers (FDA Code: HTC), ...
Zain's Medical Image is a manufacturer of surgical, dental, manicure, and single use instruments. more...
Sabri Industries | Address: Opposite Mission Hospital, Paris Road, Sialkot, Punjab 51310, Pakistan
www.nmsabri.com | Send Inquiry | Phone: +92-(52)-4274703, 4592318
FDA Registration: 3003905396 Quality: ISO 9001:2000 & ISO 13485:2003, CE Certified
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
Sabri Industries is a manufacturer and exporter of surgical & dental instruments. Our surgical instruments include sterilizing aids, scalpel handles, thermostatic forceps, needle holders, eye scissors more...
www.nmsabri.com | Send Inquiry | Phone: +92-(52)-4274703, 4592318
FDA Registration: 3003905396 Quality: ISO 9001:2000 & ISO 13485:2003, CE Certified
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
Sabri Industries is a manufacturer and exporter of surgical & dental instruments. Our surgical instruments include sterilizing aids, scalpel handles, thermostatic forceps, needle holders, eye scissors more...
Medisporex (Pvt) Ltd. | Address: Khadim Ali Rd., P.O. Box 600, Sialkot, Punjab 51310, Pakistan
www.medisporex.com.pk | Send Inquiry | Phone: +92-(52)-3554148, 3553658, 325571
FDA Registration: 8040881
Products: Bone Rasps (FDA Code: HTR), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Tonsil Dissector (FDA Code: KBM), General & Plastic Surgery Surgical Elevator (FDA Code: GEG), ENT Elevator (FDA Code: KAD), ...
Medisporex (Pvt) Ltd. manufactures surgical instruments, dental instruments, veterinary instruments and hollow ware. Our surgical instruments include operating scissors, hemostatic forceps, retractors more...
www.medisporex.com.pk | Send Inquiry | Phone: +92-(52)-3554148, 3553658, 325571
FDA Registration: 8040881
Products: Bone Rasps (FDA Code: HTR), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Tonsil Dissector (FDA Code: KBM), General & Plastic Surgery Surgical Elevator (FDA Code: GEG), ENT Elevator (FDA Code: KAD), ...
Medisporex (Pvt) Ltd. manufactures surgical instruments, dental instruments, veterinary instruments and hollow ware. Our surgical instruments include operating scissors, hemostatic forceps, retractors more...
Bashir, Jamil & Bros. Pvt. Ltd. | Address: P.O. Box 7, Khadim Ali Road, Sialkot, Punjab 51310, Pakistan
Send Inquiry | Phone: +92-(432)-3554-100
FDA Registration: 8040179 Year Established: 1957 Annual Revenues: USD 5-10 Million Employee Count: ~320 Quality: ISO 9001:2008, ISO 13485:2003, CE Certified
Products: Nasal Rasps (FDA Code: KBA), Adjustable Frequency Tuning Fork, Hertz Frequency Tuning Fork, Sensory Evaluation Tuning Fork, Aluminium Tuning Fork, Magnesium Tuning Forks, ...
Bashir, Jamil & Bros. Pvt. Ltd. is a manufacturer and exporter of manicure, surgical, scissors, dental instruments and metal fabrication of vetrinary & postmortem instruments. more...
Send Inquiry | Phone: +92-(432)-3554-100
FDA Registration: 8040179 Year Established: 1957 Annual Revenues: USD 5-10 Million Employee Count: ~320 Quality: ISO 9001:2008, ISO 13485:2003, CE Certified
Products: Nasal Rasps (FDA Code: KBA), Adjustable Frequency Tuning Fork, Hertz Frequency Tuning Fork, Sensory Evaluation Tuning Fork, Aluminium Tuning Fork, Magnesium Tuning Forks, ...
Bashir, Jamil & Bros. Pvt. Ltd. is a manufacturer and exporter of manicure, surgical, scissors, dental instruments and metal fabrication of vetrinary & postmortem instruments. 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.
