K113836 is an FDA 510(k) clearance for the BENEHOLD CHG TRANSPARENT FILM DRESSING (10X12CM) (8.5X12CM) (6.5X7 CM). This device is classified as a Dressing, Wound, Drug.
Submitted by Avery Dennison Belgie Bvba (Chicago, US). The FDA issued a Cleared decision on September 24, 2012, 271 days after receiving the submission on December 28, 2011.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K113836 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 28, 2011 |
| Decision Date | September 24, 2012 |
| Days to Decision | 271 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO - Dressing, Wound, Drug |
| Device Class | - |