FDA 510(k) Application Details - K033198

Device Classification Name	Scaler, Ultrasonic   More FDA Info for this Device
510(K) Number	K033198
Device Name	Scaler, Ultrasonic
Applicant	APOZA ENTERPRISE CO. LTD. 6 F,NO.657, CHUANG CHENG ROAD HSIN-CHUANG CITY TAIPEI HSIEN 242 TW Other 510(k) Applications for this Company
Contact	SHIH MIN-TEH 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	10/02/2003
Decision Date	04/30/2004
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	N
Expedited Review