K951862 is an FDA 510(k) clearance for the A GEL WOUND DRESSING. This device is classified as a Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic.
Submitted by Polymedica Industries, Inc. (Golden,, US). The FDA issued a Cleared decision on July 12, 1995, 82 days after receiving the submission on April 21, 1995.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K951862 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 21, 1995 |
| Decision Date | July 12, 1995 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MGQ — Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Device Class | — |