FDA 510(k) Application Details - K050541

Device Classification Name	Laser, Ophthalmic   More FDA Info for this Device
510(K) Number	K050541
Device Name	Laser, Ophthalmic
Applicant	OMNIGUIDE COMMUNICATIONS, INC. ONE KENDALL SQUARE, BLDG 100 3RD FLOOR CAMBRIDGE, MA 02139 US Other 510(k) Applications for this Company
Contact	IRINA KULINETS Other 510(k) Applications for this Contact
Regulation Number	886.4390   More FDA Info for this Regulation Number
Classification Product Code	HQF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/02/2005
Decision Date	05/09/2005
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