FDA 510(k) Application Details - K033591

Device Classification Name	Trocar, Sinus   More FDA Info for this Device
510(K) Number	K033591
Device Name	Trocar, Sinus
Applicant	CLEAR MEDICAL, INC. 1776 136TH PL. NE BELLEVUE, WA 98005 US Other 510(k) Applications for this Company
Contact	MIKE KOVACS Other 510(k) Applications for this Contact
Regulation Number	874.4420   More FDA Info for this Regulation Number
Classification Product Code	KBG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/13/2003
Decision Date	06/03/2005
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