CERAVITAL CERAMIC EAR CANAL WALL PROSTH
FDA 510(k) clearance K813224 · decided 1982-04-21
Clearance details
- K-number
- K813224
- Device name
- CERAVITAL CERAMIC EAR CANAL WALL PROSTH
- Applicant
- Xomed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-11-09
- Decision date
- 1982-04-21
- Days to decision
- 163 days
- Clearance type
- Traditional
- Product code
- ESF
- Device class
- 2
- Regulation number
- 878.3500
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- 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 |
|---|---|---|
| BEHIND-THE-EAR HEARING AID MODEL 404 PP-PC (K891247) | Siemens Hearing Instruments, Inc. | 1989-03-29 |
Recalls involving this device
No recalls on record reference this clearance.