FDA 510(k) Application Details - K043527

Device Classification Name	Instrument, Ent Manual Surgical   More FDA Info for this Device
510(K) Number	K043527
Device Name	Instrument, Ent Manual Surgical
Applicant	EXPLORAMED NC1, INC. 2570 WEST EL CAMINO REAL SUITE 310 MOUNTAIN VIEW, CA 94040 US Other 510(k) Applications for this Company
Contact	WILLIAM M FACTEAU 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	12/21/2004
Decision Date	04/05/2005
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