FDA 510(k) Application Details - K001563

Device Classification Name	Dislodger, Stone, Flexible   More FDA Info for this Device
510(K) Number	K001563
Device Name	Dislodger, Stone, Flexible
Applicant	SCION CARDIOVASCULAR, INC. 14256 SW 119 AVE. MIAMI, FL 33186 US Other 510(k) Applications for this Company
Contact	DAVID B JONES Other 510(k) Applications for this Contact
Regulation Number	876.4680   More FDA Info for this Regulation Number
Classification Product Code	FGO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/19/2000
Decision Date	11/22/2000
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