FDA 510(k) Application Details - K151522

Device Classification Name	Bronchoscope Accessory   More FDA Info for this Device
510(K) Number	K151522
Device Name	Bronchoscope Accessory
Applicant	MEDIVATORS, INC. 3150 POLLOK DR. CONROE, TX 77303 US Other 510(k) Applications for this Company
Contact	Jeff Kasoff 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	06/05/2015
Decision Date	09/17/2015
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