MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERP
FDA 510(k) clearance K896589 · decided 1989-12-27
Clearance details
- K-number
- K896589
- Device name
- MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERP
- Applicant
- Optik
- Decision
- Substantially Equivalent
- Date received
- 1989-11-21
- Decision date
- 1989-12-27
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- LRZ
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Criftib, MD, 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 |
|---|---|---|
| 1.1 SCREWDRIVERS (K872490) | Micro-Aire Surgical Instruments, Inc. | 1987-07-23 |
| STANDARD SCREW DRIVER (K872387) | Med-Tool, Inc. | 1987-07-16 |
Recalls involving this device
No recalls on record reference this clearance.