FDA 510(k) Application Details - K980492

Device Classification Name	Lithotriptor, Electro-Hydraulic   More FDA Info for this Device
510(K) Number	K980492
Device Name	Lithotriptor, Electro-Hydraulic
Applicant	CIRCON ACMI 300 STILLWATER AVE. P.O. BOX 1971 STAMFORD, CT 06904-1971 US Other 510(k) Applications for this Company
Contact	RONALD J EHMSEN 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	02/09/1998
Decision Date	11/17/1998
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