K070653 is an FDA 510(k) clearance for the KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE, MODEL 6662, a Dressing, Wound, Drug, submitted by Tyco Healthcare (Mansfield, US). The FDA issued a Cleared decision on September 12, 2007, 187 days after receiving the submission on March 9, 2007. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K070653 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 09, 2007 |
| Decision Date | September 12, 2007 |
| Days to Decision | 187 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |