GRIP-A-BOOTS
FDA 510(k) clearance K955463 · decided 1996-01-23
Clearance details
- K-number
- K955463
- Device name
- GRIP-A-BOOTS
- Applicant
- Sil-Med Corp.
- Decision
- Substantially Equivalent
- Date received
- 1995-11-29
- Decision date
- 1996-01-23
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- LXZ
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Taunton, 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 |
|---|---|---|
| INSTRUMENT TIP PROTECTION COVERS (K834127) | Devon Industries, Inc. | 1984-02-17 |
Recalls involving this device
No recalls on record reference this clearance.