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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 K150076
Device Name Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L
Applicant
Dong IL Technology , Ltd.
28 Namyang-Ro 930beon-Gil
Hwaseong-Si, Gyeonggi-Do,  KR 445-040
Applicant Contact DONG BUM KIM
Correspondent
Plusglobal
300, Atwood St.
Pittsburgh,  PA  15213
Correspondent Contact PETER CHUNG
Regulation Number872.4120
Classification Product Code
DZI  
Date Received01/14/2015
Decision Date 06/02/2015
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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