Device Classification Name |
insufflator, laparoscopic
|
510(k) Number |
K934928 |
Device Name |
INSITE FILTER & TUBING SET |
Applicant |
ANDRONIC DEVICES, LTD. |
SUITE 140 |
13120 VANIER PLACE |
RICHMOND, B.C. CANADA V6V 2J2,
CA
V6V 2J2
|
|
Applicant Contact |
ROBERT MACNEIL |
Correspondent |
ANDRONIC DEVICES, LTD. |
SUITE 140 |
13120 VANIER PLACE |
RICHMOND, B.C. CANADA V6V 2J2,
CA
V6V 2J2
|
|
Correspondent Contact |
ROBERT MACNEIL |
Regulation Number | 884.1730
|
Classification Product Code |
|
Date Received | 10/14/1993 |
Decision Date | 05/26/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|