FDA 510(k) Application Details - K062763

Device Classification Name	Microscope, Specular   More FDA Info for this Device
510(K) Number	K062763
Device Name	Microscope, Specular
Applicant	KONAN MEDICAL, INC. 377 ROUTE 17 SOUTH HASBROUCK HEIGHTS, NJ 07604 US Other 510(k) Applications for this Company
Contact	GEORGE MYERS 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	09/15/2006
Decision Date	02/22/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review