Device Classification Name |
mesh, surgical, non-synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
|
510(k) Number |
K993459 |
Device Name |
MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX |
Applicant |
ADVANCED UROSCIENCE, INC. |
1290 HAMMOND RD. |
ST. PAUL,
MN
55110
|
|
Applicant Contact |
KAREN E PETERSON |
Correspondent |
ADVANCED UROSCIENCE, INC. |
1290 HAMMOND RD. |
ST. PAUL,
MN
55110
|
|
Correspondent Contact |
KAREN E PETERSON |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 10/13/1999 |
Decision Date | 11/05/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|