FDA 510(k) Application Details - K100395

Device Classification Name	Light, Surgical, Fiberoptic   More FDA Info for this Device
510(K) Number	K100395
Device Name	Light, Surgical, Fiberoptic
Applicant	STERIS Corporation 5960 Heisley Road Mentor, OH 44060 US Other 510(k) Applications for this Company
Contact	ROBERT SULLIVAN Other 510(k) Applications for this Contact
Regulation Number	878.4580   More FDA Info for this Regulation Number
Classification Product Code	FST Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/16/2010
Decision Date	03/17/2010
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