FDA 510(k) Application Details - K130354

Device Classification Name	Splint, Intranasal Septal   More FDA Info for this Device
510(K) Number	K130354
Device Name	Splint, Intranasal Septal
Applicant	ENTRIGUE SURGICAL, INC. 12672 SILICON DR. STE 150 SAN ANTONIO, TX 78249 US Other 510(k) Applications for this Company
Contact	GABRIELE G NIEDERAUER 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	02/12/2013
Decision Date	05/29/2013
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