FDA 510(k) Application Details - K955442

Device Classification Name	Camera, Ophthalmic, Ac-Powered   More FDA Info for this Device
510(K) Number	K955442
Device Name	Camera, Ophthalmic, Ac-Powered
Applicant	KOWA OPTIMED, INC. 700 THIRTEENTH STREET, N.W. SUITE 1200 WASHINGTON, DC 20005 US Other 510(k) Applications for this Company
Contact	SAMIA N RODRIGUEZ Other 510(k) Applications for this Contact
Regulation Number	886.1120   More FDA Info for this Regulation Number
Classification Product Code	HKI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/28/1995
Decision Date	01/03/1996
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	N
Expedited Review