FDA 510(k) Application Details - K971953

Device Classification Name	Biomicroscope, Slit-Lamp, Ac-Powered   More FDA Info for this Device
510(K) Number	K971953
Device Name	Biomicroscope, Slit-Lamp, Ac-Powered
Applicant	TOMEY CORPORATION USA 325 VASSAR ST. 2ND FLOOR CAMBRIDGE, MA 02139 US Other 510(k) Applications for this Company
Contact	DAVE MACLELLAN 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	05/28/1997
Decision Date	08/14/1997
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