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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Strip, Dialysate Ph Indicator
510(k) Number K945491
Device Name SERIM(TM) BICARB PH REAGENT STRIPS
Applicant
Serim Research Corp.
P.O. Box 4002
Elkhart,  IN  46514
Applicant Contact ROBERT C BOGUSLASKI
Correspondent
Serim Research Corp.
P.O. Box 4002
Elkhart,  IN  46514
Correspondent Contact ROBERT C BOGUSLASKI
Regulation Number876.5820
Classification Product Code
MNV  
Date Received11/08/1994
Decision Date 02/01/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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