FDA 510(k) Application Details - K040373

Device Classification Name	Microscope, Specular   More FDA Info for this Device
510(K) Number	K040373
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	02/17/2004
Decision Date	03/19/2004
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