FDA 510(k) Application Details - K964891

Device Classification Name	Topographer, Corneal, Ac-Powered   More FDA Info for this Device
510(K) Number	K964891
Device Name	Topographer, Corneal, Ac-Powered
Applicant	ORBTEK, INC. 3030 SOUTH MAIN ST. SUITE 600 SALT LAKE CITY, UT 84115 US Other 510(k) Applications for this Company
Contact	PIER CALACINO Other 510(k) Applications for this Contact
Regulation Number	886.1350   More FDA Info for this Regulation Number
Classification Product Code	MMQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/06/1996
Decision Date	03/26/1997
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