K012816 is an FDA 510(k) clearance for the DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414, a Dressing, Wound, Drug, submitted by Dynarex Corp. (Mainville, US). The FDA issued a Cleared decision on October 17, 2002, 421 days after receiving the submission on August 22, 2001. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K012816 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 22, 2001 |
| Decision Date | October 17, 2002 |
| Days to Decision | 421 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |