FDA 510(k) Application Details - K152922

Device Classification Name	Bronchoscope Accessory   More FDA Info for this Device
510(K) Number	K152922
Device Name	Bronchoscope Accessory
Applicant	SPIRATION, INC. 6675 185th Ave NE REDMOND, WA 98052 US Other 510(k) Applications for this Company
Contact	Cyndy J Adams 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	10/02/2015
Decision Date	02/19/2016
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