K041268 is an FDA 510(k) clearance for the SILVERSITE OR CALGITROL, a Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic, submitted by Adri (Park Forest, US). The FDA issued a Cleared decision on September 20, 2004, 131 days after receiving the submission on May 12, 2004. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K041268 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 12, 2004 |
| Decision Date | September 20, 2004 |
| Days to Decision | 131 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 | — |