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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, hypodermic, single lumen
510(k) Number K071998
Device Name ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT
Applicant
ARROW INTL., INC.
P.O. BOX 12888
READING,  PA  19612 -2888
Applicant Contact KIRSTEN STOWELL
Correspondent
ARROW INTL., INC.
P.O. BOX 12888
READING,  PA  19612 -2888
Correspondent Contact KIRSTEN STOWELL
Regulation Number880.5570
Classification Product Code
FMI  
Date Received07/23/2007
Decision Date 09/26/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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