FDA 510(k) Application Details - K961090

Device Classification Name	Perimeter, Automatic, Ac-Powered   More FDA Info for this Device
510(K) Number	K961090
Device Name	Perimeter, Automatic, 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	HIROSHI OKADA Other 510(k) Applications for this Contact
Regulation Number	886.1605   More FDA Info for this Regulation Number
Classification Product Code	HPT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/19/1996
Decision Date	06/17/1996
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