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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
Correspondent
Tecnol New Jersey Wound Care, Inc.
368 Fairview Ave.
Hammonton,  NJ  08037
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
Predetermined Change
Control Plan Authorized		 No
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