#157 EXAM LIGHT
FDA 510(k) clearance K893949 · decided 1989-08-07
Clearance details
- K-number
- K893949
- Device name
- #157 EXAM LIGHT
- Applicant
- Medmark, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-06-01
- Decision date
- 1989-08-07
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- KFK
- Device class
- 1
- Regulation number
- 878.4820
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Versailles, OH, 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 |
|---|---|---|
| MICRO-AIRE STERNUM SAW 4800 (K894301) | Micro Surgical Instruments Corp. | 1989-08-03 |
| OSCILLATING SAW/ RECIPROCATING SAW/ DRILL-REAMER (K870157) | Micro-Aire Surgical Instruments, Inc. | 1987-02-24 |
| STERNUM SAW (K801737) | Amsco Co. | 1980-08-20 |
Recalls involving this device
No recalls on record reference this clearance.