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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, external fixator (with metallic invasive components)
510(k) Number K122208
Device Name EXTERNAL FIXATOR SYSTEM
Original Applicant
CHRISTOPHER D. ENDARA
11767 s. dixie hwy
#313
miami,  FL  33156
Original Contact christopher endara
Regulation Number888.3040
Classification Product Code
NDK  
Date Received07/25/2012
Decision Date 12/20/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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