FDA 510(k) Application Details - K103498

Device Classification Name	Scaler, Ultrasonic   More FDA Info for this Device
510(K) Number	K103498
Device Name	Scaler, Ultrasonic
Applicant	LAKONG MEDICAL DEVICE COMPANY, LTD 18525 E. GALE AVE. CITY OF INDUSTRY, CA 91748 US Other 510(k) Applications for this Company
Contact	DANNY WANG Other 510(k) Applications for this Contact
Regulation Number	872.4850   More FDA Info for this Regulation Number
Classification Product Code	ELC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/29/2010
Decision Date	03/31/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review