Device Classification Name |
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
|
510(k) Number |
K982403 |
Device Name |
BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX |
Applicant |
BRENNEN MEDICAL, INC. |
1290 HAMMOND RD. |
ST. PAUL,
MN
55110
|
|
Applicant Contact |
KENNETH B HERLAND |
Correspondent |
BRENNEN MEDICAL, INC. |
1290 HAMMOND RD. |
ST. PAUL,
MN
55110
|
|
Correspondent Contact |
KENNETH B HERLAND |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 07/10/1998 |
Decision Date | 09/22/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|