Device Classification Name |
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
|
510(k) Number |
K013718 |
Device Name |
GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR |
Applicant |
GYNECARE, A DIV. OF ETHICON, INC. |
P.O. BOX 151 |
SOMERVILLE,
NJ
08876
|
|
Applicant Contact |
GREGORY R JONES |
Correspondent |
GYNECARE, A DIV. OF ETHICON, INC. |
P.O. BOX 151 |
SOMERVILLE,
NJ
08876
|
|
Correspondent Contact |
GREGORY R JONES |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 11/08/2001 |
Decision Date | 01/08/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|