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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 K974064
Device Name MICRO X RESIDUAL TEST STRIPS
Applicant
Reprocessing Products Corp
8662 Comstock Ln.
Maple Grove,  MN  55311
Applicant Contact WALTER JANSEN
Correspondent
Reprocessing Products Corp
8662 Comstock Ln.
Maple Grove,  MN  55311
Correspondent Contact WALTER JANSEN
Regulation Number876.5665
Classification Product Code
MSY  
Date Received10/27/1997
Decision Date 12/07/1998
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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