FDA 510(k) Application Details - K243655

Device Classification Name	Splint, Intranasal Septal   More FDA Info for this Device
510(K) Number	K243655
Device Name	Splint, Intranasal Septal
Applicant	Spirair, Inc 415 Grand Avenue, Suite 201 South San Francisco, CA 94080 US Other 510(k) Applications for this Company
Contact	Tracey Henry Other 510(k) Applications for this Contact
Regulation Number	874.4780   More FDA Info for this Regulation Number
Classification Product Code	LYA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/26/2024
Decision Date	07/11/2025
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