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510(k) K913962

Device
ANOMALOSCOPE QUADRANT TEST-6
Applicant
LKC TECHNOLOGIES, INC.
510(k) number
K913962
Product code
HIW  
Decision
Substantially Equivalent (SESE)
Decision date
1991-10-23
Date received
1991-09-05
Regulation
886.1070
Classification name
Anomaloscope
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JEROME LEIGHT
Address
2 Professional Dr., Suite 222 Gaithersburg MD US 20879 20879

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HIW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K930575KAMPPETER ANOMALOSCOPEBova Intl.1994-02-25
K860174GUNKEL CHROMAGRAPH COLOR VISION TESTERChromagraphics, Inc.1986-04-04

Legacy Summary#

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FDA Review#

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