29-200 TO 29-230 VARIOUS BONE MALLETS(WIHIGER, DOY
FDA 510(k) clearance K851789 · decided 1985-06-20
Clearance details
- K-number
- K851789
- Device name
- 29-200 TO 29-230 VARIOUS BONE MALLETS(WIHIGER, DOY
- Applicant
- Artiberia
- Decision
- Substantially Equivalent
- Date received
- 1985-04-25
- Decision date
- 1985-06-20
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- GFJ
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- San Antonio, TX, 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 |
|---|---|---|
| MICROTENS 7757 T.E.N.S. STIMULATOR (K844017) | Rabar, Inc. | 1984-11-30 |
| ENT MALLETS (K822204) | Kelleher Corp. | 1982-09-17 |
Recalls involving this device
No recalls on record reference this clearance.