Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K002721 |
Device Name |
AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH |
Applicant |
AMERICAN MEDICAL SYSTEMS, INC. |
10700 BREN RD., WEST |
MINNETONKA,
MN
55343
|
|
Applicant Contact |
GINGER Z GLASER |
Correspondent |
AMERICAN MEDICAL SYSTEMS, INC. |
10700 BREN RD., WEST |
MINNETONKA,
MN
55343
|
|
Correspondent Contact |
GINGER Z GLASER |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 08/31/2000 |
Decision Date | 11/29/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|