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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 K901286
Device Name AMICON HEMOCONCENTRATOR SET
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 Received03/20/1990
Decision Date 05/18/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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