FDA 510(k) Application Details - K140088

Device Classification Name	More FDA Info for this Device
510(K) Number	K140088
Device Name	PHANTOM XL INSULATED DILATORS
Applicant	TEDAN SURGICAL INNOVATIONS, LLC 12615 W AIRPORT BLVD, SUITE 200 SUGAR LAND, TX 77478 US Other 510(k) Applications for this Company
Contact	JOANN(DIONICIA) REBLANDO Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/14/2014
Decision Date	09/25/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review