The following data is part of a premarket notification filed by Brennen Medical, Inc. with the FDA for Macropro Gel.
| Device ID | K000518 |
| 510k Number | K000518 |
| Device Name: | MACROPRO GEL |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | BRENNEN MEDICAL, INC. 1290 HAMMOND RD. St. Paul, MN 55110 |
| Contact | Phil Lawin |
| Correspondent | Phil Lawin BRENNEN MEDICAL, INC. 1290 HAMMOND RD. St. Paul, MN 55110 |
| Product Code | MGQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-16 |
| Decision Date | 2000-05-01 |