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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialyzer, High Permeability With Or Without Sealed Dialysate System
510(k) Number K000028
Device Name RENAFLO II HF 2000 HEMOFILTER
Applicant
Minntech Corp.
14905 28th Ave. N.
Minneapolis,  MN  55447
Applicant Contact RICHARD M ORMSBEE
Correspondent
Minntech Corp.
14905 28th Ave. N.
Minneapolis,  MN  55447
Correspondent Contact RICHARD M ORMSBEE
Regulation Number876.5860
Classification Product Code
KDI  
Date Received01/05/2000
Decision Date 04/04/2000
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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