FDA 510(k) Application Details - K053555

Device Classification Name	Scaler, Ultrasonic   More FDA Info for this Device
510(K) Number	K053555
Device Name	Scaler, Ultrasonic
Applicant	GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD 340 SHADY GROVE ROAD FLINTVILLE, TN 37335 US Other 510(k) Applications for this Company
Contact	CHARLIE MACK 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	12/20/2005
Decision Date	08/21/2006
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