FDA 510(k) Application Details - K121351

Device Classification Name	Instrument, Ent Manual Surgical   More FDA Info for this Device
510(K) Number	K121351
Device Name	Instrument, Ent Manual Surgical
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, PH.D. Other 510(k) Applications for this Contact
Regulation Number	874.4420   More FDA Info for this Regulation Number
Classification Product Code	LRC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/04/2012
Decision Date	08/29/2012
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