K943728 is an FDA 510(k) clearance for the BURNFREE BURNSOOTHE HYDROGEL. This device is classified as a Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic.
Submitted by Levtrade Intl. (Pty) , Ltd. (Kingham, US). The FDA issued a Cleared decision on September 27, 1994, 70 days after receiving the submission on July 19, 1994.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K943728 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | July 19, 1994 |
| Decision Date | September 27, 1994 |
| Days to Decision | 70 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 | — |