Device Classification Name |
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
|
510(k) Number |
K131229 |
Device Name |
SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS |
Applicant |
AMERICAN MEDICAL SYSTEMS |
10700 BREN ROAD WEST |
MINNETONKA,
MN
55343
|
|
Applicant Contact |
TODD HILDEBRANDT |
Correspondent |
AMERICAN MEDICAL SYSTEMS |
10700 BREN ROAD WEST |
MINNETONKA,
MN
55343
|
|
Correspondent Contact |
TODD HILDEBRANDT |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 04/30/2013 |
Decision Date | 12/05/2013 |
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
|
|
|