Device Classification Name |
Laparoscope, Gynecologic (And Accessories)
|
510(k) Number |
K940049 |
Device Name |
KNOT PUSHER, SPOON FORCEPS AND BIOPSY FORCEPS |
Applicant |
BAXTER HEALTHCARE CORP. |
1435 LAKE COOK RD. |
DEERFIELD,
IL
60015
|
|
Applicant Contact |
NICOLE CLARK |
Correspondent |
BAXTER HEALTHCARE CORP. |
1435 LAKE COOK RD. |
DEERFIELD,
IL
60015
|
|
Correspondent Contact |
NICOLE CLARK |
Regulation Number | 884.1720
|
Classification Product Code |
|
Date Received | 01/05/1994 |
Decision Date | 05/06/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|