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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name container, i.v.
510(k) Number K121161
Models ACTINFXXX, ACTINFXXXD
Device Name EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINER
Original Applicant
ACTA MEDICAL LLC
929 arbor downs sr
plano,  TX  75023
Original Contact aaron compton
Regulation Number880.5025
Classification Product Code
KPE  
Date Received04/17/2012
Decision Date 07/13/2012
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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