The following data is part of a premarket notification filed by Advanced Uroscience, Inc. with the FDA for Modification To Brennen Biosynthetic Surgical Mesh Matrix.
| Device ID | K993459 |
| 510k Number | K993459 |
| Device Name: | MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX |
| Classification | Mesh, Surgical, Non-synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| Applicant | ADVANCED UROSCIENCE, INC. 1290 HAMMOND RD. St. Paul, MN 55110 |
| Contact | Karen E Peterson |
| Correspondent | Karen E Peterson ADVANCED UROSCIENCE, INC. 1290 HAMMOND RD. St. Paul, MN 55110 |
| Product Code | PAG |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-13 |
| Decision Date | 1999-11-05 |
| Summary: | summary |