K043296 is an FDA 510(k) clearance for the COLACTIVE AG COLLAGEN WITH SILVER ANTIMICROBIAL DRESSING, a Dressing, Wound, Drug, submitted by Covalontechnologies, Inc. (Largo, US). The FDA issued a Cleared decision on June 6, 2005, 189 days after receiving the submission on November 29, 2004. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K043296 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 29, 2004 |
| Decision Date | June 06, 2005 |
| Days to Decision | 189 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |