FDA 510(k) Application Details - K171239

Device Classification Name	Tube, Tympanostomy   More FDA Info for this Device
510(K) Number	K171239
Device Name	Tube, Tympanostomy
Applicant	Tusker Medical 155 Jefferson Drive Suite 200 Menlo Park, CA 94025 US Other 510(k) Applications for this Company
Contact	Pavan Sethi Other 510(k) Applications for this Contact
Regulation Number	874.3880   More FDA Info for this Regulation Number
Classification Product Code	ETD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/27/2017
Decision Date	06/28/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review