FDA 510(k) Application Details - K203754

Device Classification Name	Device, Inflation, Middle Ear   More FDA Info for this Device
510(K) Number	K203754
Device Name	Device, Inflation, Middle Ear
Applicant	Exercore, LLC 8170 Old Carriage Court N, Suite 200 Shakopee, MN 55379 US Other 510(k) Applications for this Company
Contact	Kevin Connelly Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MJV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2020
Decision Date	02/19/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review