Device Classification Name |
Tourniquet, Gastro-Urology
|
510(k) Number |
K802850 |
Device Name |
TECNOL O.R. TOURNIQUET 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 | 878.5900
|
Classification Product Code |
|
Date Received | 11/12/1980 |
Decision Date | 01/13/1981 |
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
|