K915695 is an FDA 510(k) clearance for the PROCEL BURN COVER. This device is classified as a Dressing, Wound And Burn, Occlusive.
Submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Cleared decision on May 29, 1992, 158 days after receiving the submission on December 23, 1991.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K915695 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | December 23, 1991 |
| Decision Date | May 29, 1992 |
| Days to Decision | 158 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | MGP — Dressing, Wound And Burn, Occlusive |
| Device Class | — |