FDA 510(k) Application Details - K121035

Device Classification Name	Bronchoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K121035
Device Name	Bronchoscope (Flexible Or Rigid)
Applicant	FUJIFILM MEDICAL SYSTEM U.S.A., INC. 10 HIGH POINT DRIVE WAYNE, NJ 07470 US Other 510(k) Applications for this Company
Contact	GINA WALLJASPER 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	04/05/2012
Decision Date	06/04/2012
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