FDA 510(k) Application Details - K973064

Device Classification Name	Biomicroscope, Slit-Lamp, Ac-Powered   More FDA Info for this Device
510(K) Number	K973064
Device Name	Biomicroscope, Slit-Lamp, Ac-Powered
Applicant	KEELER INSTRUMENTS, INC. 456 PKWY. BROOMALL, PA 19008 US Other 510(k) Applications for this Company
Contact	EUGENE R VAN ARSDALE Other 510(k) Applications for this Contact
Regulation Number	886.1850   More FDA Info for this Regulation Number
Classification Product Code	HJO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/18/1997
Decision Date	04/07/1998
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