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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dialyzer, capillary, hollow fiber
510(k) Number K850654
Device Name TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KID
Applicant
ERIKA, INC.
ONE ERIKA PLAZA
ROCKLEIGH,  NJ  07647
Applicant Contact DEL DONNA
Correspondent
ERIKA, INC.
ONE ERIKA PLAZA
ROCKLEIGH,  NJ  07647
Correspondent Contact DEL DONNA
Regulation Number876.5820
Classification Product Code
FJI  
Date Received02/19/1985
Decision Date 03/07/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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