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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 K023007
Device Name DISTAL RADIUS FRACTURE REPAIR SYSTEM
Applicant
HAND INNOVATIONS, INC.
510 stonemont dr.
weston,  FL  33326
Contact richard d bliss
Regulation Number888.3030
Classification Product Code
HRS  
Date Received09/09/2002
Decision Date 12/05/2002
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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