FDA 510(k) Application Details - K110489

Device Classification Name	Biomicroscope, Slit-Lamp, Ac-Powered   More FDA Info for this Device
510(K) Number	K110489
Device Name	Biomicroscope, Slit-Lamp, Ac-Powered
Applicant	TOPCON MEDICAL SYSTEMS, INC. 5 TIMBER LANE NORTH READING, MA 01864 US Other 510(k) Applications for this Company
Contact	MAUREEN O'CONNELL Other 510(k) Applications for this Contact
Regulation Number	886.1850   More FDA Info for this Regulation Number
Classification Product Code	HJO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/22/2011
Decision Date	05/23/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review