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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 K121620
Model SMARTHOR
Device Name ULTRASONIC SURGERY
Original Applicant
DMETEC CO., LTD.
4568 w. 1st street
suite 104
los angeles,  CA  90004
Original Contact daniel nam
Regulation Number872.4120
Classification Product Code
DZI  
Date Received06/01/2012
Decision Date 12/11/2012
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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