K963623 is an FDA 510(k) clearance for the SPYROFLEX PIGMENTED WOUND DRESSING. This device is classified as a Dressing, Wound And Burn, Occlusive.
Submitted by Polymedica Industries, Inc. (Golden, US). The FDA issued a Cleared decision on October 25, 1996, 44 days after receiving the submission on September 11, 1996.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K963623 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 1996 |
| Decision Date | October 25, 1996 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MGP — Dressing, Wound And Burn, Occlusive |
| Device Class | — |