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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
Device Name ULTRASONIC SURGERY
Applicant
DMETEC CO., LTD.
4568 W. 1ST STREET
SUITE 104
LOS ANGELES,  CA  90004
Applicant Contact DANIEL NAM
Correspondent
DMETEC CO., LTD.
4568 W. 1ST STREET
SUITE 104
LOS ANGELES,  CA  90004
Correspondent Contact DANIEL NAM
Regulation Number872.4120
Classification Product Code
DZI  
Date Received06/01/2012
Decision Date 12/11/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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