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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 K935471
Device Name FILTRYZER(TM)
Applicant
TORAY INDUSTRIES (AMERICA), INC.
1-1-1 SONOYAMA
OTSU-SHI, SHIGA-KEN 520,  JP 520
Applicant Contact LISA S JONES
Correspondent
TORAY INDUSTRIES (AMERICA), INC.
1-1-1 SONOYAMA
OTSU-SHI, SHIGA-KEN 520,  JP 520
Correspondent Contact LISA S JONES
Regulation Number876.5820
Classification Product Code
FJI  
Subsequent Product Code
KDI  
Date Received11/15/1993
Decision Date 05/19/1995
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
Recalls CDRH Recalls
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