K955463 is an FDA 510(k) clearance for the GRIP-A-BOOTS. This device is classified as a Guard, Instrument (Class I - General Controls, product code LXZ).
Submitted by Sil-Med Corp. (Taunton, US). The FDA issued a Cleared decision on January 23, 1996, 55 days after receiving the submission on November 29, 1995.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K955463 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 29, 1995 |
| Decision Date | January 23, 1996 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LXZ — Guard, Instrument |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |