Device Classification Name |
laparoscope, gynecologic (and accessories)
|
510(k) Number |
K940709 |
Device Name |
SCISSORS, GRASPING FORCEPS, NEEDLE HOLDERS, DISSECTORS |
Applicant |
BAXTER HEALTHCARE CORP. |
1435 LAKE COOK RD. |
DEERFIELD,
IL
60015
|
|
Applicant Contact |
NICOLE M CLARK |
Correspondent |
BAXTER HEALTHCARE CORP. |
1435 LAKE COOK RD. |
DEERFIELD,
IL
60015
|
|
Correspondent Contact |
NICOLE M CLARK |
Regulation Number | 884.1720
|
Classification Product Code |
|
Date Received | 02/17/1994 |
Decision Date | 05/19/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|