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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 K091614
Device Name OSTEOMED FOOT PLATING SYSTEM
Original Applicant
OSTEOMED L.P.
3885 arapaho rd.
addison,  TX  75001
Original Contact alma relja
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received06/03/2009
Decision Date 09/10/2009
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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