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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scaler, Ultrasonic
510(k) Number K140233
Device Name ULTRASONIC SCALER
Applicant
Nanning Baolai Medical Instrument Co., Ltd.
Level 7, Jin Gui Business Center
982 Cunyun Rd. Baiyun District
Guangzhou, Guangdong,  CN 510420
Applicant Contact MIKE GU
Correspondent
Nanning Baolai Medical Instrument Co., Ltd.
Level 7, Jin Gui Business Center
982 Cunyun Rd. Baiyun District
Guangzhou, Guangdong,  CN 510420
Correspondent Contact MIKE GU
Regulation Number872.4850
Classification Product Code
ELC  
Date Received01/30/2014
Decision Date 04/06/2015
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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