RUBIN BONE PLANER W/REPLACEABLE BLADE
FDA 510(k) clearance K884473 · decided 1988-12-09
Clearance details
- K-number
- K884473
- Device name
- RUBIN BONE PLANER W/REPLACEABLE BLADE
- Applicant
- Neo Contemporary Co.
- Decision
- Substantially Equivalent
- Date received
- 1988-10-25
- Decision date
- 1988-12-09
- Days to decision
- 45 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
- Quincy, 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 |
|---|---|---|
| MORGAN ARTHROSCOPIC MENESUS & SYNOVIAL RASP (K853601) | Bowen & Company, Inc. | 1985-09-16 |
Recalls involving this device
No recalls on record reference this clearance.