FDA.reportPublic FDA data

510(k) K946226

Device
CUSTOM OCULAR PROSTHESIS
Applicant
FRANK TANAKA, OCULARIST, INC.
510(k) number
K946226
Product code
HQH  
Decision
Substantially Equivalent (SESE)
Decision date
1995-03-22
Date received
1994-12-22
Regulation
886.3200
Classification name
Eye, Artificial, Non-custom
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
K F TANAKA
Address
3000 E. Fletcher Ave., Suite 310 Tampa FL US 33613 33613

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
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#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases