FDA 510(k) Application Details - K102791

Device Classification Name	Light, Surgical, Accessories   More FDA Info for this Device
510(K) Number	K102791
Device Name	Light, Surgical, Accessories
Applicant	IMAGE STREAM MEDICAL, INC. ONE MONARCH DR. LITTLETON, MA 01460 US Other 510(k) Applications for this Company
Contact	BETH CYR 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	09/27/2010
Decision Date	11/23/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review