FDA 510(k) Application Details - K081698

Device Classification Name	Light, Surgical, Accessories   More FDA Info for this Device
510(K) Number	K081698
Device Name	Light, Surgical, Accessories
Applicant	IMAGE STREAM MEDICAL, INC. 11 MYSTIC AVE. WINCHESTER, MA 01890-2920 US Other 510(k) Applications for this Company
Contact	CHAS BURR Other 510(k) Applications for this Contact
Regulation Number	878.4580   More FDA Info for this Regulation Number
Classification Product Code	FTA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/17/2008
Decision Date	07/30/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review