K113583 is an FDA 510(k) clearance for the CURAD ANTIBACTERIAL BANDAGE. This device is classified as a Dressing, Wound, Drug.
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on April 12, 2012, 129 days after receiving the submission on December 5, 2011.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K113583 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 2011 |
| Decision Date | April 12, 2012 |
| Days to Decision | 129 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |