FDA 510(k) Application Details - K013111

Device Classification Name	Bronchoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K013111
Device Name	Bronchoscope (Flexible Or Rigid)
Applicant	BRONCUS TECHNOLOGIES, INC. 1400 NORTH SHORELINE BLVD., #A8 MOUNTAIN VIEW, CA 94043-1346 US Other 510(k) Applications for this Company
Contact	TIMOTHY R WILLIAMS Other 510(k) Applications for this Contact
Regulation Number	874.4680   More FDA Info for this Regulation Number
Classification Product Code	EOQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/18/2001
Decision Date	10/01/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review