FDA 510(k) Application Details - K993046

Device Classification Name	Lithotriptor, Ultrasonic   More FDA Info for this Device
510(K) Number	K993046
Device Name	Lithotriptor, Ultrasonic
Applicant	FIBRA SONICS, INC. 5312 N. ELSTON AVE. CHICAGO, IL 60630 US Other 510(k) Applications for this Company
Contact	ROBERT BROHM Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	FEO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/10/1999
Decision Date	11/22/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review