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510(k) K923670

Device
BYRNE EXPULSIVE LENS
Applicant
OCULAR INSTRUMENTS, INC.
510(k) number
K923670
Product code
HJI  
Decision
Substantially Equivalent (SESE)
Decision date
1992-11-16
Date received
1992-07-22
Regulation
886.1395
Classification name
Lens, Fundus, Hruby, Diagnostic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
TAMSIN J ERICKSON
Address
2255 116th Ave., NE Bellevue WA US 98004 98004

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HJI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K90183960 FUNDUS CAMERA CF-60UVCanon USA, Inc.1990-07-05
K902138STRIPE PROJECTORAcademic Catalyst Corp.1990-07-05
K897186LASER IMAGING WORK STATIONInnovision Medical, Inc.1990-03-12
K820223OMS QUARTZ INFUSION CONTACT LENSOptical Micro Systems, Inc.1982-02-05
K802927SEBESTYEN IRRIGATING CONTACT LENSCooper Medical Devices Corp.1981-02-05
K802971LANDERS CONTACT LENSCooper Medical Devices Corp.1981-02-05
K760949CHARLES IRRIGATING FUNDUS CONTACT LENSRichard'S Medical Equip., Inc.1976-11-11

Legacy Summary#

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FDA Review#

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