Device Classification Name |
Operating Room Accessories Table Tray
|
510(k) Number |
K813030 |
Device Name |
O.R. ARMBOARD COVER |
Applicant |
TECNOL NEW JERSEY WOUND CARE, INC. |
368 FAIRVIEW AVE. |
HAMMONTON,
NJ
08037 -0268
|
|
Correspondent |
TECNOL NEW JERSEY WOUND CARE, INC. |
368 FAIRVIEW AVE. |
HAMMONTON,
NJ
08037 -0268
|
|
Regulation Number | 878.4950
|
Classification Product Code |
|
Date Received | 10/28/1981 |
Decision Date | 01/18/1982 |
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
|