FDA 510(k) Application Details - K090660

Device Classification Name	Bronchoscope Accessory   More FDA Info for this Device
510(K) Number	K090660
Device Name	Bronchoscope Accessory
Applicant	ACCLARENT, INC. 1525-B O'BRIEN DR. MENLO PARK, CA 94025 US Other 510(k) Applications for this Company
Contact	KERI YEN Other 510(k) Applications for this Contact
Regulation Number	874.4680   More FDA Info for this Regulation Number
Classification Product Code	KTI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/12/2009
Decision Date	06/12/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review