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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 K850866
Device Name TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1L
Applicant
Erika, Inc.
One Erika Plz.
Rockleigh,  NJ  07647
Applicant Contact DEL DONNA
Correspondent
Erika, Inc.
One Erika Plz.
Rockleigh,  NJ  07647
Correspondent Contact DEL DONNA
Regulation Number876.5860
Classification Product Code
KDI  
Date Received03/01/1985
Decision Date 04/03/1985
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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