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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 K980164
Device Name STERICHEK PERACETIC ACID REAGENT STRIPS
Applicant
Environmental Test Systems, Inc.
P.O. Box 4659
Elkhart,  IN  46514
Applicant Contact BRUCE G PIEKARSKI
Correspondent
Environmental Test Systems, Inc.
P.O. Box 4659
Elkhart,  IN  46514
Correspondent Contact BRUCE G PIEKARSKI
Regulation Number876.5665
Classification Product Code
MSY  
Subsequent Product Code
LIF  
Date Received01/16/1998
Decision Date 04/16/1998
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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