Device Classification Name |
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
|
510(k) Number |
K012628 |
Device Name |
GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM |
Applicant |
GYNECARE CENTER |
P.O. BOX 151 |
SOMERVILLE,
NJ
08876 -0151
|
|
Applicant Contact |
GREGORY JONES |
Correspondent |
GYNECARE CENTER |
P.O. BOX 151 |
SOMERVILLE,
NJ
08876 -0151
|
|
Correspondent Contact |
GREGORY JONES |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 08/13/2001 |
Decision Date | 10/26/2001 |
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
|
|
|