FDA 510(k) Application Details - K202623

Device Classification Name	Splint, Intranasal Septal   More FDA Info for this Device
510(K) Number	K202623
Device Name	Splint, Intranasal Septal
Applicant	Medtronic Xomed 6743 Southpoint Drive North Jacksonville, FL 32256 US Other 510(k) Applications for this Company
Contact	Matthew Harmon 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	09/10/2020
Decision Date	12/08/2020
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