Device Classification Name |
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
|
510(k) Number |
K011251 |
FOIA Releasable 510(k) |
K011251
|
Device Name |
SPARC SLING SYSTEM |
Applicant |
AMERICAN MEDICAL SYSTEMS, INC. |
10700 BREN RD., WEST |
MINNETONKA,
MN
55343
|
|
Applicant Contact |
GINGER S GLASER |
Correspondent |
AMERICAN MEDICAL SYSTEMS, INC. |
10700 BREN RD., WEST |
MINNETONKA,
MN
55343
|
|
Correspondent Contact |
GINGER S GLASER |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 04/24/2001 |
Decision Date | 08/01/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|