CUSTOM OCULAR PROSTHESIS— 510(k) K946226

Name: FDA 510(k) clearance K946226
Creator: U.S. Food and Drug Administration
Published: 1995-03-22

Substantially Equivalent

Frank Tanaka, Ocularist, Inc.

FDA 510(k) clearance K946226 for CUSTOM OCULAR PROSTHESIS, Substantially Equivalent on 1995-03-22. Applicant: Frank Tanaka, Ocularist, Inc.. Device class: 1.

Clearance details

Applicant: Frank Tanaka, Ocularist, Inc.
Product code: Code HQH
Device class: Class 1
Regulation: 21 CFR 886.3200
Advisory panel: Ophthalmic
Date received: 1994-12-22
Decision date: 1995-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HQH

view all

K952538 — ROBERT B. SCOTT PLASTIC ARTIFICAL1995-06-26
K945270 — CUSTOM ARTIFICIAL HUMAN EYES1995-05-30
K923167 — THE NISSEL ARTIFICIAL EYE1992-09-02
K904962 — EYE ARTIFICIAL CUSTOM1991-08-30
K791923 — SCLERAL POWDER1980-01-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.