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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 K862153
Device Name ARROW 18GA TWO-LUMEN INTRAVENOUS CATH/23GA NEEDLE
Applicant
ARROW INTL., INC.
P.O. BOX 6306
HILL AND GEORGE AVENUES
READING,  PA  19610
Applicant Contact RONALD P CITRON
Correspondent
ARROW INTL., INC.
P.O. BOX 6306
HILL AND GEORGE AVENUES
READING,  PA  19610
Correspondent Contact RONALD P CITRON
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received06/05/1986
Decision Date 12/11/1986
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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