Device Classification Name |
mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
|
510(k) Number |
K023516 |
Device Name |
MONARC SLING SYSTEM |
Applicant |
AMERICAN MEDICAL SYSTEMS, INC. |
10700 BREN RD., WEST |
MINNETONKA,
MN
55343
|
|
Applicant Contact |
David Worrell |
Correspondent |
AMERICAN MEDICAL SYSTEMS, INC. |
10700 BREN RD., WEST |
MINNETONKA,
MN
55343
|
|
Correspondent Contact |
David Worrell |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 10/21/2002 |
Decision Date | 11/19/2002 |
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
|
Recalls |
CDRH Recalls
|
|
|