K022416 is an FDA 510(k) clearance for the CONTREET FOAM ADHESIVE/NON-ADHESIVE. This device is classified as a Dressing, Wound, Drug.
Submitted by Coloplast Corp. (North Mankato, US). The FDA issued a Cleared decision on February 3, 2003, 194 days after receiving the submission on July 24, 2002.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K022416 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 24, 2002 |
| Decision Date | February 03, 2003 |
| Days to Decision | 194 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |