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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name appliance, fixation, spinal intervertebral body
510(k) Number K112809
Device Name BLUE MOUNTAIN CERVICAL PLATE
Original Applicant
QUALGENIX LLC
1 jack's hill road
unit 3e
oxford,  CT  06478
Original Contact richard deslauriers
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received11/10/2011
Decision Date 06/20/2012
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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