FDA 510(k) Application Details - K050895

Device Classification Name	Scaler, Ultrasonic   More FDA Info for this Device
510(K) Number	K050895
Device Name	Scaler, Ultrasonic
Applicant	SATELEC 17 AVENUE GUSTAVE EIFFEL Z.I. DU PHARE BP 216 MERIGNAC, GIRONDE 33708 FR Other 510(k) Applications for this Company
Contact	PASCAL DUPEYRON 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	04/08/2005
Decision Date	04/20/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review