FDA 510(k) Application Details - K111342

Device Classification Name	Illuminator, Fiberoptic, Surgical Field   More FDA Info for this Device
510(K) Number	K111342
Device Name	Illuminator, Fiberoptic, Surgical Field
Applicant	SCHOTT NORTH AMERICA 40 PLAIN STREET NORTH ATTLEBORO, MA 02760 US Other 510(k) Applications for this Company
Contact	JEFFREY ROBERTS Other 510(k) Applications for this Contact
Regulation Number	878.4580   More FDA Info for this Regulation Number
Classification Product Code	HBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/13/2011
Decision Date	11/25/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review