FDA 510(k) Application Details - K123139

Device Classification Name	Scaler, Ultrasonic   More FDA Info for this Device
510(K) Number	K123139
Device Name	Scaler, Ultrasonic
Applicant	ASI MEDICAL, INC. 14550 E EASTER AVE. SUITE 700 CENTENNIAL, CO 80112 US Other 510(k) Applications for this Company
Contact	JOHN MCPEEK 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	10/05/2012
Decision Date	03/28/2013
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