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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 K914123
Device Name SERIM RESIDUAL FORMALDEHYDE REAGENT STRIPS
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 Received09/13/1991
Decision Date 04/09/1992
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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