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510(k) K904962

Device
EYE ARTIFICIAL CUSTOM
Applicant
MIDWEST EYE LABORATORIES, INC.
510(k) number
K904962
Product code
HQH  
Decision
Substantially Equivalent (SESE)
Decision date
1991-08-30
Date received
1990-11-05
Regulation
886.3200
Classification name
Eye, Artificial, Non-custom
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MICHAEL BARRETT
Address
9975 Lyndale Ave. So. Gettysburg Office Ctr. #550 Minneapolis MN US 55420 55420

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HQH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K952538ROBERT B. SCOTT PLASTIC ARTIFICALRobert B. Scott Ocularists of Florida, Inc.1995-06-26
K945270CUSTOM ARTIFICIAL HUMAN EYESDaniel T Acosta1995-05-30
K946226CUSTOM OCULAR PROSTHESISFrank Tanaka, Ocularist, Inc.1995-03-22
K923167THE NISSEL ARTIFICIAL EYENissel , Ltd.1992-09-02
K791923SCLERAL POWDEROcularists , Ltd.1980-01-10

Legacy Summary#

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FDA Review#

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