K022587 is an FDA 510(k) clearance for the MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS. This device is classified as a Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic.
Submitted by Medtrade Products , Ltd. (Crewe, GB). The FDA issued a Cleared decision on August 22, 2003, 382 days after receiving the submission on August 5, 2002.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K022587 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 2002 |
| Decision Date | August 22, 2003 |
| Days to Decision | 382 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 | — |