K964398 is an FDA 510(k) clearance for the SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED. 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 24, 1997, 354 days after receiving the submission on November 4, 1996.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K964398 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 04, 1996 |
| Decision Date | October 24, 1997 |
| Days to Decision | 354 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MGP — Dressing, Wound And Burn, Occlusive |
| Device Class | — |