OPTICAL FRAMES AND/OR SUNGLASSES— 510(k) K935729

Name: FDA 510(k) clearance K935729
Creator: U.S. Food and Drug Administration
Published: 1994-02-16

Substantially Equivalent

Ivo Eyewear, Inc.

FDA 510(k) clearance K935729 for OPTICAL FRAMES AND/OR SUNGLASSES, Substantially Equivalent on 1994-02-16. Applicant: Ivo Eyewear, Inc.. Device class: 1.

Clearance details

Applicant: Ivo Eyewear, Inc.
Product code: Code HQZ
Device class: Class 1
Regulation: 21 CFR 886.5842
Advisory panel: Ophthalmic
Date received: 1993-12-01
Decision date: 1994-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HQZ

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K952597 — VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, SUN POCKETS, POINT OF VIEW1995-09-12
K944313 — SPECTACLE FRAME1995-03-28
K945176 — SPECTACLE FRAME OR EYEGLASS FRAMES1994-12-15
K945392 — SPECTACLE FRAME1994-12-15
K945770 — OPTICAL FRAMES1994-12-15

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