OMEGA BIVALVE NASAL SPLINTS
FDA 510(k) clearance K871073 · decided 1987-05-11
Clearance details
- K-number
- K871073
- Device name
- OMEGA BIVALVE NASAL SPLINTS
- Applicant
- Omega Silicone, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-03-18
- Decision date
- 1987-05-11
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- FYI
- Device class
- 1
- Regulation number
- 878.3250
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Santa Barbara, CA, US
- 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 |
|---|---|---|
| ETHICON EXTERNAL FIXATION WIRE (K821178) | ETHICON, Inc. | 1983-06-11 |
| STRAITH NASAL SPLINT (K801072) | Surgical Technology Laboratories, Inc. | 1980-06-17 |
| CONPHAR O.R. HEAD COVER-STERILE (K792106) | Conphar, Inc. | 1979-11-05 |
Recalls involving this device
No recalls on record reference this clearance.