K000518 is an FDA 510(k) clearance for the MACROPRO GEL. This device is classified as a Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic.
Submitted by Brennen Medical, Inc. (St, Paul, US). The FDA issued a Cleared decision on May 1, 2000, 75 days after receiving the submission on February 16, 2000.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K000518 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 16, 2000 |
| Decision Date | May 01, 2000 |
| Days to Decision | 75 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 | — |