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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 K863823
Device Name AMICON DIAFILTER HEMOFILTER
Applicant
Amicon, Inc.
17 Cherry Hill Dr.
Danvers,  MA  01923
Applicant Contact JAMES M DELANEY
Correspondent
Amicon, Inc.
17 Cherry Hill Dr.
Danvers,  MA  01923
Correspondent Contact JAMES M DELANEY
Regulation Number876.5860
Classification Product Code
KDI  
Date Received09/30/1986
Decision Date 11/06/1986
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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