FDA 510(k) Application Details - K071826

Device Classification Name	More FDA Info for this Device
510(K) Number	K071826
Device Name	THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910
Applicant	FOX HOLLOW TECHNOLOGIES 740 BAY ROAD REDWOOD CITY, CA 94063 US Other 510(k) Applications for this Company
Contact	SRIDEVI SHESHADRI Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/03/2007
Decision Date	11/09/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review