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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 K900263
Device Name ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER
Applicant
ARROW INTL., INC.
P.O. BOX 6306
HILL AND GEORGE AVENUES
READING,  PA  19610
Applicant Contact THOMAS D NICKEL
Correspondent
ARROW INTL., INC.
P.O. BOX 6306
HILL AND GEORGE AVENUES
READING,  PA  19610
Correspondent Contact THOMAS D NICKEL
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received01/18/1990
Decision Date 07/24/1990
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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