FDA 510(k) Application Details - K100401

Device Classification Name	Scaler, Ultrasonic   More FDA Info for this Device
510(K) Number	K100401
Device Name	Scaler, Ultrasonic
Applicant	HU-FRIEDY MFG. CO., INC 3232 N. ROCKWELL STREET CHICAGO, IL 60618 US Other 510(k) Applications for this Company
Contact	MARIA VRABIE 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	02/16/2010
Decision Date	03/30/2010
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