K050842 is an FDA 510(k) clearance for the AGCEL WOUND DRESSING,AGCEL BURN DRESSING. This device is classified as a Dressing, Wound, Drug.
Submitted by Modern Medical Equipment Mfg., Ltd. (Richmond, US). The FDA issued a Cleared decision on August 2, 2006, 488 days after receiving the submission on April 1, 2005.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K050842 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 2005 |
| Decision Date | August 02, 2006 |
| Days to Decision | 488 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |