K983042 is an FDA 510(k) clearance for the SWEEN 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 November 25, 1998, 86 days after receiving the submission on August 31, 1998.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K983042 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 31, 1998 |
| Decision Date | November 25, 1998 |
| Days to Decision | 86 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 | — |