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510(k) K952538

Device
ROBERT B. SCOTT PLASTIC ARTIFICAL
Applicant
ROBERT B. SCOTT OCULARISTS OF FLORIDA, INC.
510(k) number
K952538
Product code
HQH  
Decision
Substantially Equivalent (SESE)
Decision date
1995-06-26
Date received
1995-05-31
Regulation
886.3200
Classification name
Eye, Artificial, Non-custom
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
RANDAL E MINOR
Address
3500 E. Fletcher Ave. Suite 502 Tampa FL US 33613 33613

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
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
K904962EYE ARTIFICIAL CUSTOMMidwest Eye Laboratories, Inc.1991-08-30
K791923SCLERAL POWDEROcularists , Ltd.1980-01-10

Legacy Summary#

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FDA Review#

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