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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K872754
Device Name HEALTH-PAK/WYCOMBE CSR WRAP
Applicant
Health-Pak, Inc.
P.O. Box 4255
Utica,  NY  13504
Applicant Contact ANTHONY LIBERATORE
Correspondent
Health-Pak, Inc.
P.O. Box 4255
Utica,  NY  13504
Correspondent Contact ANTHONY LIBERATORE
Regulation Number880.6850
Classification Product Code
FRG  
Date Received07/13/1987
Decision Date 08/06/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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