K022995 is an FDA 510(k) clearance for the COLLATEK HYDROGEL. This device is classified as a Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic.
Submitted by Biocore Medical Technologies, Inc. (Silver Spring, US). The FDA issued a Cleared decision on December 2, 2002, 84 days after receiving the submission on September 9, 2002.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K022995 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 2002 |
| Decision Date | December 02, 2002 |
| Days to Decision | 84 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 | — |