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510(k) K904961

Device
ARTIFICIAL SCLERAL SHELL
Applicant
MIDWEST EYE LABORATORIES, INC.
510(k) number
K904961
Product code
HQT  
Decision
Substantially Equivalent (SESE)
Decision date
1991-08-30
Date received
1990-11-05
Regulation
886.3800
Classification name
Shell, Scleral
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
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 HQT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K970320SCLERAL SHELLXavier A. Guerra, Ocularist, Inc.1997-07-07
K970327SCLERAL SHELLSouthwest Artificial Eyes, Inc.1997-07-07
K855105SIMMONS SHELLMira, Inc.1986-03-31

Legacy Summary#

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FDA Review#

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