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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 K823288
Device Name AMICON DIAFILTERS 20 & 30 HEMOFILTERS
Applicant
AMICON, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
AMICON, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number876.5860
Classification Product Code
KDI  
Date Received11/04/1982
Decision Date 12/16/1982
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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