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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 K002775
Device Name DISTAL VOLAR RADIUS FRACTURE REPAIR SYSTEM
Original Applicant
HAND INNOVATIONS, INC.
19526 east lake dr.
miami,  FL  33015
Original Contact al weisenborn
Regulation Number888.3030
Classification Product Code
HRS  
Date Received09/06/2000
Decision Date 12/05/2000
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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