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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name plate, cranioplasty, preformed, alterable
510(k) Number K122049
Device Name NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM
Original Applicant
KINAMED, INC.
820 flynn rd.
camarillo,  CA  93012
Original Contact heather neely
Regulation Number882.5320
Classification Product Code
GWO  
Subsequent Product Codes
GXR   HBW  
Date Received07/12/2012
Decision Date 04/05/2013
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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