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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 K883407
Device Name TORAY FILTRYZER BK SERIES
Applicant
Toray Industries (America), Inc.
280 Park Ave.
New York,  NY  10017
Applicant Contact KOHKI UENO
Correspondent
Toray Industries (America), Inc.
280 Park Ave.
New York,  NY  10017
Correspondent Contact KOHKI UENO
Regulation Number876.5860
Classification Product Code
KDI  
Date Received08/11/1988
Decision Date 02/27/1989
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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