K013525 is an FDA 510(k) clearance for the CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM). This device is classified as a Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic.
Submitted by Coloplast Corp. (North Mankato, US). The FDA issued a Cleared decision on October 4, 2002, 346 days after receiving the submission on October 23, 2001.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K013525 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 23, 2001 |
| Decision Date | October 04, 2002 |
| Days to Decision | 346 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MGQ — Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Device Class | — |