FDA 510(k) Application Details - K180141

Device Classification Name	Splint, Intranasal Septal   More FDA Info for this Device
510(K) Number	K180141
Device Name	Splint, Intranasal Septal
Applicant	SPIWay, LLC 3600 Corte Castillo Carlsbad, CA 92009 US Other 510(k) Applications for this Company
Contact	Eugene Chen 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	01/18/2018
Decision Date	02/16/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review