FDA 510(k) Application Details - K122494

Device Classification Name	Splint, Intranasal Septal   More FDA Info for this Device
510(K) Number	K122494
Device Name	Splint, Intranasal Septal
Applicant	HEMOSTASIS, LLC 5000 Township Pkwy Saint Paul, MN 55110 US Other 510(k) Applications for this Company
Contact	BERNARD HORWATH 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	08/16/2012
Decision Date	03/27/2013
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