Device Classification Name |
mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling
|
510(k) Number |
K070065 |
Device Name |
AMS SINGLE INCISION SLING SYSTEM (SIS-0) |
Applicant |
AMERICAN MEDICAL SYSTEMS, INC. |
10700 BREN RD., WEST |
MINNETONKA,
MN
55343
|
|
Applicant Contact |
BRAD ONSTAD |
Correspondent |
AMERICAN MEDICAL SYSTEMS, INC. |
10700 BREN RD., WEST |
MINNETONKA,
MN
55343
|
|
Correspondent Contact |
BRAD ONSTAD |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 01/08/2007 |
Decision Date | 03/01/2007 |
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
|
|
|