FDA 510(k) Application Details - K130565

Device Classification Name	Microscope, Specular   More FDA Info for this Device
510(K) Number	K130565
Device Name	Microscope, Specular
Applicant	NIDEK CO., LTD. 300 BRICKSTONE SQUARE ANDOVER, MA 01810 US Other 510(k) Applications for this Company
Contact	Aron Shapiro Other 510(k) Applications for this Contact
Regulation Number	886.1850   More FDA Info for this Regulation Number
Classification Product Code	NQE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/04/2013
Decision Date	11/27/2013
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