FDA 510(k) Application Details - K113430

Device Classification Name	Scaler, Ultrasonic   More FDA Info for this Device
510(K) Number	K113430
Device Name	Scaler, Ultrasonic
Applicant	SATELEC-ACTEON GROUP 124 GAITHER DRIVE , SUITE 140 MT LAUREL, NJ 08054 US Other 510(k) Applications for this Company
Contact	RICK ROSATI 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	11/21/2011
Decision Date	02/23/2012
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