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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector, Leak, Blood
510(k) Number K123805
Device Name E-Z CHEK BLOOD LEAK TEST STRIPS
Applicant
REPROCESSING PRODUCTS CORP.
P.O. BOX 35849
TUCSON,  AZ  85740
Applicant Contact TED WILLIAMS
Correspondent
REPROCESSING PRODUCTS CORP.
P.O. BOX 35849
TUCSON,  AZ  85740
Correspondent Contact TED WILLIAMS
Regulation Number876.5820
Classification Product Code
FJD  
Date Received12/11/2012
Decision Date 03/20/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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