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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 K103498
Device Name LAKONG ULTRASONIC SCALER
Applicant
Lakong Medical Device Company, Ltd.
18525 E. Gale Ave.
City Of Industry,  CA  91748
Applicant Contact DANNY WANG
Correspondent
Lakong Medical Device Company, Ltd.
18525 E. Gale Ave.
City Of Industry,  CA  91748
Correspondent Contact DANNY WANG
Regulation Number872.4850
Classification Product Code
ELC  
Date Received11/29/2010
Decision Date 03/31/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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