FDA 510(k) Application Details - K153484

Device Classification Name	Bronchoscope Accessory   More FDA Info for this Device
510(K) Number	K153484
Device Name	Bronchoscope Accessory
Applicant	INTUIT MEDICAL PRODUCTS, LLC 6018 EAGLES REST TRAIL SUGAR HILL, GA 30518 US Other 510(k) Applications for this Company
Contact	JACK GRIFFIS 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	12/03/2015
Decision Date	07/27/2016
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