K953618 is an FDA 510(k) clearance for the SPYROFLEX 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 August 21, 1995, 18 days after receiving the submission on August 3, 1995.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K953618 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | August 03, 1995 |
| Decision Date | August 21, 1995 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | MGP — Dressing, Wound And Burn, Occlusive |
| Device Class | — |