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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 K940910
Device Name FILTRYZER
Applicant
Toray Industries (America), Inc.
600 Third Ave.
New York,  NY  10016
Applicant Contact LISA S JONES
Correspondent
Toray Industries (America), Inc.
600 Third Ave.
New York,  NY  10016
Correspondent Contact LISA S JONES
Regulation Number876.5820
Classification Product Code
FJI  
Subsequent Product Code
KDI  
Date Received02/25/1994
Decision Date 05/04/1995
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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