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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name orthosis, spine, plate, laminoplasty, metal
510(k) Number K121276
Device Name NEURO VENTION LAMINPLASTY PLATING SYSTEM
Original Applicant
NEUROVENTION LLC
4628 northpark drive
meredith may,  CO  80918
Original Contact meredith may
Regulation Number888.3050
Classification Product Code
NQW  
Date Received04/27/2012
Decision Date 08/29/2012
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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