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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 K993691
Device Name ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER
Original Applicant
ARROW INTL., INC.
2400 bernville rd.
reading,  PA  19605
Original Contact thomas d nickel
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received11/01/1999
Decision Date 03/08/2000
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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