K033453 is an FDA 510(k) clearance for the KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING, a Dressing, Wound, Drug, submitted by Tyco Healthcare (Mansfield, US). The FDA issued a Cleared decision on April 29, 2004, 182 days after receiving the submission on October 30, 2003. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K033453 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 30, 2003 |
| Decision Date | April 29, 2004 |
| Days to Decision | 182 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |