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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 K121803
Device Name INTRAVASCULAR ADMINISTRATION SET
Original Applicant
ACTA MEDICAL LLC
15 minneakoning rd. suite 203
flemington,  NJ  08822
Original Contact john brewer
Regulation Number880.5440
Classification Product Code
FPA  
Date Received06/19/2012
Decision Date 12/19/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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