FDA 510(k) Application Details - K974796

Device Classification Name	Lithotriptor, Electro-Hydraulic   More FDA Info for this Device
510(K) Number	K974796
Device Name	Lithotriptor, Electro-Hydraulic
Applicant	MEDISPEC, LTD. 19110 MONTGOMERY VILLAGE AVE. SUITE 100 MONTGOMERY VILLAGE, MD 20886 US Other 510(k) Applications for this Company
Contact	AVNER SPECTOR Other 510(k) Applications for this Contact
Regulation Number	876.4480   More FDA Info for this Regulation Number
Classification Product Code	FFK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/1997
Decision Date	03/12/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review