K112549 is an FDA 510(k) clearance for the IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER, a Dressing, Wound, Drug, submitted by Covalontechnologies, Inc. (Mississauga, Ontario, CA). The FDA issued a Cleared decision on May 4, 2012, 246 days after receiving the submission on September 1, 2011. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K112549 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 01, 2011 |
| Decision Date | May 04, 2012 |
| Days to Decision | 246 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |