Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- 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)
- K863382CANNON NASAL SPLINT1Cleared 510(K)
- K862496MICROTEK INTRANASAL SPLINT1Cleared 510(K)
- K810738GOODE MAGNETIC NASAL SPLINT1Cleared 510(K)
- K791681THE DENVER SPLINT1Cleared 510(K)
- K791053THE DENVER SPLINT1Cleared 510(K)
- 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
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
THE DENVER SPLINT
- Page Type
- Cleared 510(K)
- 510(k) Number
- K791681
- 510(k) Type
- Traditional
- Applicant
- XOMED, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/22/1979
- Days to Decision
- 55 days