Device Classification Name |
mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
|
510(k) Number |
K033568 |
FOIA Releasable 510(k) |
K033568
|
Device Name |
GYNECARE TVT OBTURATOR SYSTEM |
Applicant |
ETHICON, INC. |
P.O BOX 151, ROUTE 22 WEST |
SOMERVILLE,
NJ
08876
|
|
Applicant Contact |
SEAN O'BRYAN |
Correspondent |
ETHICON, INC. |
P.O BOX 151, ROUTE 22 WEST |
SOMERVILLE,
NJ
08876
|
|
Correspondent Contact |
SEAN O'BRYAN |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 11/12/2003 |
Decision Date | 12/08/2003 |
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
|
|
|