FDA 510(k) Application Details - K221254

Device Classification Name	Tube, Tympanostomy   More FDA Info for this Device
510(K) Number	K221254
Device Name	Tube, Tympanostomy
Applicant	Preceptis Medical, Inc. 10900 89th Avenue North, Suite 4 Maple Grove, MN 55369 US Other 510(k) Applications for this Company
Contact	Steve Anderson 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	05/02/2022
Decision Date	07/27/2022
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