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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 -0002
Applicant Contact MICHAEL MCKENNA
Correspondent
SERIM RESEARCH CORP.
P.O. BOX 4002
ELKHART,  IN  46514 -0002
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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