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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 K052294
Device Name SHOULDER NAIL PLATE
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 Received08/23/2005
Decision Date 10/21/2005
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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