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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 (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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