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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name set, administration, intravascular
510(k) Number K112073
Model RX-2001, RX-2201, RX-2211
Device Name INFUSITE NEEDLELESS ACCES DEVICE (STERILE, BULK NON-STERILE) AND INFUSITE NEEDLELESS ACCESS DEVICE 'Y' ADAPTER (BULK...
Original Applicant
RX DEVICES LLC
19200 ashville hwy
landrum,  SC  29356 9021
Original Contact charles hokanson
Regulation Number880.5440
Classification Product Code
FPA  
Date Received07/20/2011
Decision Date 04/11/2012
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
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