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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name wire, guide, catheter
510(k) Number K040100
Device Name ARROW ECHOGENIC INTRODUCER NEEDLE
Applicant
ARROW INTL., INC.
2400 BERNVILLE RD.
P.O. BOX 12888
READING,  PA  19605
Applicant Contact WILLIAM G MCLAIN
Correspondent
ARROW INTL., INC.
2400 BERNVILLE RD.
P.O. BOX 12888
READING,  PA  19605
Correspondent Contact WILLIAM G MCLAIN
Regulation Number870.1330
Classification Product Code
DQX  
Date Received01/20/2004
Decision Date 03/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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