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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 K111419
Device Name OSTEOMED HAND FUSION SYSTEM
Applicant
OSTEOMED L.P.
3885 arapaho rd.
addison,  TX  75001
Contact suzanne cheang
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received05/20/2011
Decision Date 10/07/2011
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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