FDA 510(k) Application Details - K223542

Device Classification Name	More FDA Info for this Device
510(K) Number	K223542
Device Name	TubaVent Balloon Dilatation System
Applicant	Spiggle & Theis Medizintechnik GmbH Burghof 4 Overath 51491 DE Other 510(k) Applications for this Company
Contact	Claudia Winterschladen Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/25/2022
Decision Date	08/03/2023
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