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510(k) K964702

Device
EUCLID SYSTEMS CORNEAL TOPOGRAPHER MODEL ET800
Applicant
EUCLID SYSTEMS CORP.
510(k) number
K964702
Product code
MMQ  
Decision
Substantially Equivalent (SESE)
Decision date
1997-05-20
Date received
1996-11-25
Regulation
886.1350
Classification name
Topographer, Corneal, Ac-powered
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
ANNE MARIE CESARIO, R.A.C.
Address
1129 Bloomfield Ave. West Cadwell NJ US 07006 07006

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MMQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K981665SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICEBio-Medical Sciences, Inc.1998-12-07
K964891ORBSHOT KERATOMETEROrbtek, Inc.1997-03-26
K963762CORNEAL TOPOGRAPHER 200Eclipse Ventures1996-12-23
K950077INTRAOPERATIVE CORNEAL TOPOGRAPHY SYSTEM (I-CTS)Par Vision Systems Corp.1995-06-14

Legacy Summary#

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FDA Review#

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