FDA 510(k) Application Details - K100644

Device Classification Name	Ophthalmoscope,Laser,Scanning   More FDA Info for this Device
510(K) Number	K100644
Device Name	Ophthalmoscope,Laser,Scanning
Applicant	OPTOS PLC 555 THIRTEENTH ST. N.W. COLUMBIA SQUARE WASHINGTON, DC 20004-1109 US Other 510(k) Applications for this Company
Contact	HOWARD M HOLSTEIN Other 510(k) Applications for this Contact
Regulation Number	886.1570   More FDA Info for this Regulation Number
Classification Product Code	MYC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/05/2010
Decision Date	07/15/2010
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