3M(TM) SURGICAL SLIPPER, 9660 SERIES
FDA 510(k) clearance K946162 · decided 1995-01-24
Clearance details
- K-number
- K946162
- Device name
- 3M(TM) SURGICAL SLIPPER, 9660 SERIES
- Applicant
- Wahl Clipper Corp.
- Decision
- Substantially Equivalent
- Date received
- 1994-12-19
- Decision date
- 1995-01-24
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- LWK
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Steriling, IL, 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 |
|---|---|---|
| SURGICAL CLIPPER (K910524) | Baxter Healthcare Corp | 1991-03-28 |
| SURGICAL PREP RAZOR (K874370) | Derma-Safe Co. | 1987-11-13 |
| SURGICAL PREP RAZOR, STRAIGHT TYPE (K874234) | Derma-Safe Co. | 1987-11-02 |
Recalls involving this device
No recalls on record reference this clearance.