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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 K904210
Device Name RENATRON II DIALYZER REPROCESSING SYSTEM RS 8330
Applicant
Minntech Corp.
14605 28th Ave. N.
Minneapolis,  MN  55447
Applicant Contact LEROY FISCHBACH
Correspondent
Minntech Corp.
14605 28th Ave. N.
Minneapolis,  MN  55447
Correspondent Contact LEROY FISCHBACH
Regulation Number876.5820
Classification Product Code
LIF  
Date Received09/12/1990
Decision Date 11/27/1990
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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