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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name plate, fixation, bone
510(k) Number K060294
Device Name DIAPHYSEAL PLATE
Original Applicant
HAND INNOVATIONS, LLC.
8905 sw 87th avenue,
suite 220
miami lakes,  FL  33176
Original Contact ernesto hernandez
Regulation Number888.3030
Classification Product Code
HRS  
Date Received02/07/2006
Decision Date 03/22/2006
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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