K950934 is an FDA 510(k) clearance for the MPM HYDROGEL DRESSING. This device is classified as a Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic.
Submitted by Richard Hamer Assoc., Inc. (Fort Worth, US). The FDA issued a Cleared decision on May 16, 1995, 76 days after receiving the submission on March 1, 1995.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K950934 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | March 01, 1995 |
| Decision Date | May 16, 1995 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | MGQ — Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Device Class | — |