K002078 is an FDA 510(k) clearance for the BETA GLUCAN GEL (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 October 2, 2000, 84 days after receiving the submission on July 10, 2000.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K002078 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 10, 2000 |
| Decision Date | October 02, 2000 |
| Days to Decision | 84 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 | — |