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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 K840449
Device Name AMICON DIAFILTER 40. HEMOFILTER
Applicant
Medical Device Consultants, Inc.
49 Plain St.
North Attleboro,  MA  02760
Correspondent
Medical Device Consultants, Inc.
49 Plain St.
North Attleboro,  MA  02760
Regulation Number876.5860
Classification Product Code
KDI  
Date Received02/01/1984
Decision Date 03/23/1984
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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