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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialyzer Reprocessing System
510(k) Number K900341
Device Name SERIM RESIDUAL PEROXIDE/RENALIN TEST KIT
Applicant
Serim Research Corp.
P.O. Box 4002
Elkhart,  IN  46514
Applicant Contact MICHAEL MCKENNA
Correspondent
Serim Research Corp.
P.O. Box 4002
Elkhart,  IN  46514
Correspondent Contact MICHAEL MCKENNA
Regulation Number876.5820
Classification Product Code
LIF  
Date Received01/22/1990
Decision Date 07/11/1990
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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