MORGAN ARTHROSCOPIC MENESUS & SYNOVIAL RASP
FDA 510(k) clearance K853601 · decided 1985-09-16
Clearance details
- K-number
- K853601
- Device name
- MORGAN ARTHROSCOPIC MENESUS & SYNOVIAL RASP
- Applicant
- Bowen & Company, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-08-27
- Decision date
- 1985-09-16
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- GAC
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Rockville, 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 |
|---|---|---|
| RUBIN BONE PLANER W/REPLACEABLE BLADE (K884473) | Neo Contemporary Co. | 1988-12-09 |
Recalls involving this device
No recalls on record reference this clearance.