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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name orthopedic stereotaxic instrument
510(k) Number K120867
Device Name VIPER AND EXPEDIUM NAVIGATED INSTRUMENTS
Original Applicant
MEDOS INTERNATIONAL SARL
325 paramount drive
raynham,  MA  02767
Original Contact laura bleyendaal
Regulation Number882.4560
Classification Product Code
OLO  
Date Received03/22/2012
Decision Date 09/20/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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