The following data is part of a premarket notification filed by Brennen Medical, Inc. with the FDA for Brennen Biosynthetic Surgical Mesh Matrix.
| Device ID | K982403 |
| 510k Number | K982403 |
| Device Name: | BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX |
| Classification | Mesh, Surgical, Non-synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| 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 | PAG |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-10 |
| Decision Date | 1998-09-22 |