Device Classification Name |
coagulator, culdoscopic (and accessories)
|
510(k) Number |
K925114 |
Device Name |
LAPAROSCOPIC INSTRUMENTS |
Applicant |
ENDO TECHNIC CORP. |
3027 COMMERICAL AVE. |
NORTHBROOK,
IL
60062
|
|
Applicant Contact |
DAM GUDEMAN |
Correspondent |
ENDO TECHNIC CORP. |
3027 COMMERICAL AVE. |
NORTHBROOK,
IL
60062
|
|
Correspondent Contact |
DAM GUDEMAN |
Regulation Number | 884.4160
|
Classification Product Code |
|
Date Received | 10/09/1992 |
Decision Date | 02/28/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|