K040517 is an FDA 510(k) clearance for the TENDERWET ACTIVE. This device is classified as a Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic.
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on March 25, 2004, 27 days after receiving the submission on February 27, 2004.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K040517 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 27, 2004 |
| Decision Date | March 25, 2004 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | MGQ — Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Device Class | — |