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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 K882158
Device Name MODIFIED TORAY FILTRYZER DIALYZERS
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 Number876.5820
Classification Product Code
FJI  
Date Received05/23/1988
Decision Date 08/12/1988
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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