FDA 510(k) Application Details - K062259

Device Classification Name	Endoilluminator   More FDA Info for this Device
510(K) Number	K062259
Device Name	Endoilluminator
Applicant	ISCIENCE SURGICAL 4055 CAMPBELL AVENUE MENLO PARK, CA 94025 US Other 510(k) Applications for this Company
Contact	GRACE BARTOO Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	MPA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/04/2006
Decision Date	08/15/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review