Device Classification Name |
laparoscope, gynecologic (and accessories)
|
510(k) Number |
K904104 |
Device Name |
ENDOPATH UNSHIELDED DISPOSABLE SURGICAL TROCAR |
Applicant |
ETHICON, INC. |
ROUTE 22 WEST |
P.O. BOX 151 |
SOMERVILLE,
NJ
08876 -0151
|
|
Applicant Contact |
JAMES P O'DONNELL |
Correspondent |
ETHICON, INC. |
ROUTE 22 WEST |
P.O. BOX 151 |
SOMERVILLE,
NJ
08876 -0151
|
|
Correspondent Contact |
JAMES P O'DONNELL |
Regulation Number | 884.1720
|
Classification Product Code |
|
Date Received | 09/06/1990 |
Decision Date | 12/05/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|