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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
510(k) Number K872762
Device Name TORAY ANTHRON AORTA BYPASS TUBES
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 Number870.4210
Classification Product Code
DWF  
Date Received07/13/1987
Decision Date 09/24/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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