FDA 510(k) Application Details - K110205

Device Classification Name	Ophthalmoscope, Ac-Powered   More FDA Info for this Device
510(K) Number	K110205
Device Name	Ophthalmoscope, Ac-Powered
Applicant	APPASAMY ASSOCIATES 20, SBI OFFICERS COLONY 1ST STREET ARUMBAKKAM, CHENNAI 600 106 IN Other 510(k) Applications for this Company
Contact	K RENGASAMY Other 510(k) Applications for this Contact
Regulation Number	886.1570   More FDA Info for this Regulation Number
Classification Product Code	HLI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/25/2011
Decision Date	02/09/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	Y
Expedited Review