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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 K052248
Device Name DORSAL NAIL PLATE, ANATOMICAL
Original Applicant
HAND INNOVATIONS, LLC.
8905 sw 87th avenue
suite 220
miami,  FL  33176
Original Contact ernesto hernandez
Regulation Number888.3030
Classification Product Code
HRS  
Date Received08/18/2005
Decision Date 09/14/2005
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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