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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name drill, bone, powered
510(k) Number K122322
Device Name PIEZOSURGERY TOUCH
Original Applicant
MECTRON S.P.A.
piazza albania 10
rome,  IT 00153
Original Contact roger gray
Regulation Number872.4120
Classification Product Code
DZI  
Subsequent Product Code
ELC  
Date Received08/01/2012
Decision Date 12/06/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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