EPP — Splint, Nasal Class I
FDA product code EPP covers "Splint, Nasal", a Class I medical device regulated under 21 CFR 874.5800. Submissions are reviewed by the Ear, Nose, Throat panel. At least 15 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- EPP
- Device Class
- Class I
- Regulation Number
- 874.5800
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K942158 | wfr/aquaplast | AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS | July 29, 1994 |
| K942724 | micromed development | EXTERNAL NASAL SPLINT | July 8, 1994 |
| K895502 | microbio-medics | MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT | December 8, 1989 |
| K890599 | hood laboratories | HOOD NASAL SPLINT | March 17, 1989 |
| K882244 | richards medical co | RICHARDS THERMOPLASTIC DORSAL NASAL SPLINT | June 23, 1988 |
| K872905 | american silk sutures | AMERICAN NASAL SPONGE | September 4, 1987 |
| K864930 | exmoor plastics | 'EXMOOR' ATKINS NASAL SPLINT | March 4, 1987 |
| K864933 | exmoor plastics | 'EXMOOR' SHAH & MACKAY NASAL SPLINTS | March 4, 1987 |
| K864932 | exmoor plastics | 'EXMOOR' CAWOOD NASAL SPLINTS | March 4, 1987 |
| K864934 | exmoor plastics | 'EXMOOR' SHAH SILICONE DISCS | January 28, 1987 |
| K863382 | treace medical | CANNON NASAL SPLINT | October 7, 1986 |
| K862496 | microtek medical | MICROTEK INTRANASAL SPLINT | July 14, 1986 |
| K810738 | xomed | GOODE MAGNETIC NASAL SPLINT | March 31, 1981 |
| K791681 | xomed | THE DENVER SPLINT | October 22, 1979 |
| K791053 | ronald d. shippert, m.d | THE DENVER SPLINT | August 16, 1979 |