FDA 510(k) Application Details - K232702

Device Classification Name	Tube, Tympanostomy   More FDA Info for this Device
510(K) Number	K232702
Device Name	Tube, Tympanostomy
Applicant	AventaMed DAC Rubicon Centre, Rossa Avenue, Bishopstown T12 Y275 IE Other 510(k) Applications for this Company
Contact	Keith Jansen 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	09/05/2023
Decision Date	05/20/2024
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