Anesthesiology
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- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- OGPCricothyrotomy Kit2Product Code
- OGVTracheostomy Cleaning Tray2Product Code
- OGWTracheostomy Kit2Product Code
- MYBPillow, Cervical (For Mild Sleep Apnea)2Product Code
- EPNPump, Nebulizer, Manual1Product Code
- EPPSplint, Nasal1Product Code
- K942158AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS1Cleared 510(K)
- K942724EXTERNAL NASAL SPLINT1Cleared 510(K)
- K895502MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT1Cleared 510(K)
- K890599HOOD NASAL SPLINT1Cleared 510(K)
- K882244RICHARDS THERMOPLASTIC DORSAL NASAL SPLINT1Cleared 510(K)
- K872905AMERICAN NASAL SPONGE1Cleared 510(K)
- K864933'EXMOOR' SHAH & MACKAY NASAL SPLINTS1Cleared 510(K)
- K864932'EXMOOR' CAWOOD NASAL SPLINTS1Cleared 510(K)
- K864930'EXMOOR' ATKINS NASAL SPLINT1Cleared 510(K)
- K864934'EXMOOR' SHAH SILICONE DISCS1Cleared 510(K)
Show All 15 Submissions
- ETFUnit, Examining/Treatment, Ent1Product Code
- EWTDevice, Antichoke, Suction3Product Code
- EWWDevice, Antichoke, Tongs3Product Code
- JPWPump, Nebulizer, Electrically Powered1Product Code
- KCJApplicator, Ent1Product Code
- KCLBlower, Powder, Ent1Product Code
- KCMDropper, Ent1Product Code
- KCNEar Wick1Product Code
- KCONasal Spray, Ent Delivery1Product Code
- KCPSyringe, Ent1Product Code
- KMAIrrigator, Powered Nasal1Product Code
- KTHDevice, Anti-Stammering1Product Code
- LRDApplicator, Ent Drug1Product Code
- PKAExternal Upper Esophageal Sphincter (Ues) Compression Device2Product Code
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- Gastroenterology and UrologyReview Panel
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AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS
- Page Type
- Cleared 510(K)
- 510(k) Number
- K942158
- 510(k) Type
- Traditional
- Applicant
- WFR/AQUAPLAST CORP.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/29/1994
- Days to Decision
- 87 days
- Submission Type
- Statement