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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 K113152
Device Name ULTRASONIC SURGERY MACHINE
Applicant
Dmetec.Co., Ltd.
1415-1441 Gardena Ave.
Glendale,  CA  91204
Applicant Contact DANIEL NAM
Correspondent
Dmetec.Co., Ltd.
1415-1441 Gardena Ave.
Glendale,  CA  91204
Correspondent Contact DANIEL NAM
Regulation Number872.4120
Classification Product Code
DZI  
Date Received10/25/2011
Decision Date 06/14/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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