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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Dialysate Delivery, Single Patient
510(k) Number K953854
Device Name WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDE
Applicant
Integrated Biomedical Technology, Inc.
51819 Winding Waters Ln.
Elkhart,  IN  46514
Applicant Contact WEN H WU
Correspondent
Integrated Biomedical Technology, Inc.
51819 Winding Waters Ln.
Elkhart,  IN  46514
Correspondent Contact WEN H WU
Regulation Number876.5820
Classification Product Code
FKP  
Date Received08/07/1995
Decision Date 03/11/1996
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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