Device Classification Name |
operating room accessories table tray
|
510(k) Number |
K821933 |
Device Name |
OMNISURG SIDE MOUNTING CLAMP & RAIL EXT. |
Applicant |
POLAMEDCO, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
POLAMEDCO, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 878.4950
|
Classification Product Code |
|
Date Received | 06/29/1982 |
Decision Date | 07/08/1982 |
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
|