FDA 510(k) Application Details - K082750

Device Classification Name	Septal Stapler/Absorbable Staples   More FDA Info for this Device
510(K) Number	K082750
Device Name	Septal Stapler/Absorbable Staples
Applicant	ENTRIGUE SURGICAL, INC. 12672 SILICON DRIVE SUITE 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	878.4750   More FDA Info for this Regulation Number
Classification Product Code	OLL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/19/2008
Decision Date	01/06/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review