The following data is part of a premarket notification filed by Brennen Medical, Inc. with the FDA for Brennen Medical Beta Glucan Cream, Macropro.
| Device ID | K980962 |
| 510k Number | K980962 |
| Device Name: | BRENNEN MEDICAL BETA GLUCAN CREAM, MACROPRO |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | BRENNEN MEDICAL, INC. 1290 HAMMOND RD. St. Paul, MN 55110 |
| Contact | Kenneth B Herland |
| Correspondent | Kenneth B Herland 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 | 1998-03-16 |
| Decision Date | 1998-07-29 |