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U.S. Department of Health and Human Services

510(k) Premarket Notification

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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 Number878.4950
Classification Product Code
FWZ  
Date Received10/28/1981
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
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