K060952 is an FDA 510(k) clearance for the COLLAGEN NERVE WRAP. This device is classified as a Cuff, Nerve (Class II - Special Controls, product code JXI).
Submitted by Collagen Matrix, Inc. (Franklin Lakes, US). The FDA issued a Cleared decision on July 14, 2006, 99 days after receiving the submission on April 6, 2006.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5275.
| 510(k) Number | K060952 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 2006 |
| Decision Date | July 14, 2006 |
| Days to Decision | 99 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | JXI — Cuff, Nerve |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5275 |