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 |