Device Classification Name |
fixation, non-absorbable or absorbable, for pelvic use
|
510(k) Number |
K042603 |
Device Name |
GYNECARE PROLENE FASTENER 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 | 884.4530
|
Classification Product Code |
|
Date Received | 09/24/2004 |
Decision Date | 12/22/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|