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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cranial distraction system
510(k) Number K121304
Device Name OSTEOMED CRANIAL DISTRACTION SYSTEM
Original Applicant
OSTEOMED
3885 arapaho rd
addison,  TX  75001
Original Contact piedad pena
Regulation Number882.5330
Classification Product Code
PBJ  
Date Received05/01/2012
Decision Date 08/22/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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