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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name syringe, piston
510(k) Number K121124
Device Name ARTHREX MIXING AND DELIVERY SYSTEM
Original Applicant
ARTHREX, INC.
1370 creekside blvd.
naples,  FL  34108 1945
Original Contact christina flores
Regulation Number880.5860
Classification Product Code
FMF  
Date Received04/13/2012
Decision Date 05/16/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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