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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
510(k) Number K132344
Device Name E-Z CHECK OZONE TEST STRIPS
Applicant
Reprocessing Products Corporation (Rpc)
1643 W. Modern Ct.
Tucson,  AZ  85705
Applicant Contact MICHAEL HONSTEIN
Correspondent
Reprocessing Products Corporation (Rpc)
1643 W. Modern Ct.
Tucson,  AZ  85705
Correspondent Contact MICHAEL HONSTEIN
Regulation Number876.5665
Classification Product Code
MSY  
Date Received07/29/2013
Decision Date 02/25/2014
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
Predetermined Change
Control Plan Authorized		 No
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