FDA 510(k) Application Details - K080494

Device Classification Name	Rongeur, Manual   More FDA Info for this Device
510(K) Number	K080494
Device Name	Rongeur, Manual
Applicant	BAXANO, INC. 5582 CHALON ROAD YORBA LINDA, CA 92886 US Other 510(k) Applications for this Company
Contact	SHARON ROCKWELL Other 510(k) Applications for this Contact
Regulation Number	882.4840   More FDA Info for this Regulation Number
Classification Product Code	HAE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/22/2008
Decision Date	03/04/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review