K991202 is an FDA 510(k) clearance for the MODIFICATION TO WOUN'DRES. 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 June 4, 1999, 74 days after receiving the submission on March 22, 1999.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K991202 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 22, 1999 |
| Decision Date | June 04, 1999 |
| Days to Decision | 74 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 | — |