Device Classification Name |
mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling
|
510(k) Number |
K100807 |
Device Name |
MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191 |
Applicant |
AMERICAN MEDICAL SYSTEMS, INC. |
10700 BREN RD., WEST |
MINNETONKA,
MN
55343
|
|
Applicant Contact |
DONNA SEMLAK |
Correspondent |
AMERICAN MEDICAL SYSTEMS, INC. |
10700 BREN RD., WEST |
MINNETONKA,
MN
55343
|
|
Correspondent Contact |
DONNA SEMLAK |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 03/22/2010 |
Decision Date | 06/07/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|