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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name powered laser surgical instrument
510(k) Number K120561
Device Name NEUROBLATE SYSTEM
Original Applicant
MONTERIS MEDICAL, INC.
100 - 78 innovation drive
winnipeg,  CA r3t 6c2
Original Contact jeff wilson
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
HAW  
Date Received02/24/2012
Decision Date 04/01/2013
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
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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