MODIFICATION OF ANTERIOR SEGMENT ELECTRODES
FDA 510(k) clearance K933527 · decided 1994-01-25
Clearance details
- K-number
- K933527
- Device name
- MODIFICATION OF ANTERIOR SEGMENT ELECTRODES
- Applicant
- Mira, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-07-20
- Decision date
- 1994-01-25
- Days to decision
- 189 days
- Clearance type
- Traditional
- Product code
- HWA
- Device class
- 1
- Regulation number
- 888.4540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Waltham, MA, 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 |
|---|---|---|
| RAYLOR(TM) MALLET (K864422) | Cedar Surgical, Inc. | 1986-11-24 |
| MALLET (K841627) | Plastafil, Inc. | 1984-08-27 |
| CEMENT CHISELS (K770205) | Depuy, Inc. | 1977-02-08 |
Recalls involving this device
No recalls on record reference this clearance.