FDA 510(k) Application Details - K974467

Device Classification Name	Biomicroscope, Slit-Lamp, Ac-Powered   More FDA Info for this Device
510(K) Number	K974467
Device Name	Biomicroscope, Slit-Lamp, Ac-Powered
Applicant	AESCULAP-MEDITEC NORTH AMERICA 23832 VIA MONTE COTO DE CAZA, CA 92679-4001 US Other 510(k) Applications for this Company
Contact	WILLIAM T KELLEY 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	11/26/1997
Decision Date	02/19/1998
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