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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 K991851
Device Name RENACLEAR DIALYZER CLEANING SYSTEM
Applicant
Minntech Corp.
14605 28th Ave. N.
Minneapolis,  MN  55447
Applicant Contact RICHARD M ORMSBEE
Correspondent
Minntech Corp.
14605 28th Ave. N.
Minneapolis,  MN  55447
Correspondent Contact RICHARD M ORMSBEE
Regulation Number876.5820
Classification Product Code
LIF  
Date Received06/01/1999
Decision Date 08/30/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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