K033869 is an FDA 510(k) clearance for the CONTREET FOAM CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.). This device is classified as a Dressing, Wound, Drug.
Submitted by Coloplast Corp. (North Mankato, US). The FDA issued a Cleared decision on May 17, 2004, 157 days after receiving the submission on December 12, 2003.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K033869 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 12, 2003 |
| Decision Date | May 17, 2004 |
| Days to Decision | 157 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |