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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 K964264
Device Name HIGH RANGE PEROXIDE TEST STRIP
Applicant
INTEGRATED BIOMEDICAL TECHNOLOGY, INC.
2931 MOOSE TRAIL
ELKHART,  IN  46514
Applicant Contact WEN H WU
Correspondent
INTEGRATED BIOMEDICAL TECHNOLOGY, INC.
2931 MOOSE TRAIL
ELKHART,  IN  46514
Correspondent Contact WEN H WU
Regulation Number876.5820
Classification Product Code
FKP  
Subsequent Product Code
LIF  
Date Received10/25/1996
Decision Date 06/16/1997
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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