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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
Applicant
CHRISTOPHER D. ENDARA
11767 S. DIXIE HWY
#313
MIAMI,  FL  33156
Applicant Contact CHRISTOPHER ENDARA
Correspondent
CHRISTOPHER D. ENDARA
11767 S. DIXIE HWY
#313
MIAMI,  FL  33156
Correspondent Contact CHRISTOPHER ENDARA
Regulation Number888.3040
Classification Product Code
NDK  
Date Received07/25/2012
Decision Date 12/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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