'EXMOOR' SHAH & MACKAY NASAL SPLINTS
FDA 510(k) clearance K864933 · decided 1987-03-04
Clearance details
- K-number
- K864933
- Device name
- 'EXMOOR' SHAH & MACKAY NASAL SPLINTS
- Applicant
- Exmoor Plastics , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1986-12-16
- Decision date
- 1987-03-04
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- EPP
- Device class
- 1
- Regulation number
- 874.5800
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Taunton, GB
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS (K942158) | Wfr/Aquaplast Corp. | 1994-07-29 |
| EXTERNAL NASAL SPLINT (K942724) | Micromed Development Corp. | 1994-07-08 |
| MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT (K895502) | Microbio-Medics, Inc. | 1989-12-08 |
| HOOD NASAL SPLINT (K890599) | Hood Laboratories | 1989-03-17 |
| RICHARDS THERMOPLASTIC DORSAL NASAL SPLINT (K882244) | Richards Medical Co., Inc. | 1988-06-23 |
| AMERICAN NASAL SPONGE (K872905) | American Silk Sutures, Inc. | 1987-09-04 |
| 'EXMOOR' ATKINS NASAL SPLINT (K864930) | Exmoor Plastics , Ltd. | 1987-03-04 |
| 'EXMOOR' CAWOOD NASAL SPLINTS (K864932) | Exmoor Plastics , Ltd. | 1987-03-04 |
| 'EXMOOR' SHAH SILICONE DISCS (K864934) | Exmoor Plastics , Ltd. | 1987-01-28 |
| CANNON NASAL SPLINT (K863382) | Treace Medical, Inc. | 1986-10-07 |
| MICROTEK INTRANASAL SPLINT (K862496) | Microtek Medical, Inc. | 1986-07-14 |
| GOODE MAGNETIC NASAL SPLINT (K810738) | Xomed, Inc. | 1981-03-31 |
Recalls involving this device
No recalls on record reference this clearance.