BIOSP. TOTAL OSSICULAR REPLACE. PROSTHE.
FDA 510(k) clearance K771725 · decided 1977-09-26
Clearance details
- K-number
- K771725
- Device name
- BIOSP. TOTAL OSSICULAR REPLACE. PROSTHE.
- Applicant
- Xomed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-09-13
- Decision date
- 1977-09-26
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- FEX
- Device class
- 1
- Regulation number
- 876.5090
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Arnold, MO, 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 |
|---|---|---|
| PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1 (K911104) | Hgm Medical Laser Systems, Inc. | 1991-06-11 |
Recalls involving this device
No recalls on record reference this clearance.