FDA 510(k) Application Details - K232059

Device Classification Name	Tube, Tympanostomy   More FDA Info for this Device
510(K) Number	K232059
Device Name	Tube, Tympanostomy
Applicant	Grace Medical, Inc. 8500 Wolf Lake Drive, Suite 110 Memphis, TN 38133 US Other 510(k) Applications for this Company
Contact	Mark Melton 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	07/11/2023
Decision Date	11/24/2023
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