FDA 510(k) Application Details - K982793

Device Classification Name	Scaler, Ultrasonic   More FDA Info for this Device
510(K) Number	K982793
Device Name	Scaler, Ultrasonic
Applicant	ADVANCED MEDICAL DEVICES, INC. 3722 AVE SAUSALITO IRVINE, CA 92606 US Other 510(k) Applications for this Company
Contact	GREG HOLLAND 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	08/10/1998
Decision Date	10/28/1998
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