Device Classification Name |
Laparoscope, Gynecologic (And Accessories)
|
510(k) Number |
K941206 |
Device Name |
DUAL VALVE ASPIRATION/LAVAGE CANNULA AND ASPIRATION/SUCTION PROBE |
Applicant |
NEW EDER CORP. |
1451-E LANDMEIER RD. |
ELK GROOVE VILLAGE,
IL
60007
|
|
Applicant Contact |
JAIRO E CANAVERAL |
Correspondent |
NEW EDER CORP. |
1451-E LANDMEIER RD. |
ELK GROOVE VILLAGE,
IL
60007
|
|
Correspondent Contact |
JAIRO E CANAVERAL |
Regulation Number | 884.1720
|
Classification Product Code |
|
Date Received | 03/14/1994 |
Decision Date | 07/25/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|