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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
Applicant
ARTHREX, INC.
1370 CREEKSIDE BLVD.
NAPLES,  FL  34108 -1945
Applicant Contact CHRISTINA FLORES
Correspondent
ARTHREX, INC.
1370 CREEKSIDE BLVD.
NAPLES,  FL  34108 -1945
Correspondent 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 Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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