Device Classification Name |
Operating Room Accessories Table Tray
|
510(k) Number |
K935381 |
Device Name |
KAPS POSITIONING ARM |
Applicant |
ANDRONIC DEVICES, LTD. |
140-13120 VANIER PLACE |
RICHMOND,B.C. CANADA,
CA
V6V2J2
|
|
Applicant Contact |
ROBERT MACNEIL |
Correspondent |
ANDRONIC DEVICES, LTD. |
140-13120 VANIER PLACE |
RICHMOND,B.C. CANADA,
CA
V6V2J2
|
|
Correspondent Contact |
ROBERT MACNEIL |
Regulation Number | 878.4950
|
Classification Product Code |
|
Date Received | 11/08/1993 |
Decision Date | 04/15/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|