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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K881236
Device Name TORAY ANTHRON P-U CATHETERS
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 Number880.5200
Classification Product Code
FOZ  
Date Received03/22/1988
Decision Date 05/11/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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