THE LENS OR OMMI-GARD— 510(k) K800521

Substantially Equivalent

Gentex Corporation

FDA 510(k) clearance K800521 for THE LENS OR OMMI-GARD, Substantially Equivalent on 1980-03-12. Applicant: Gentex Corporation. Device class: 1.

Clearance details

Applicant: Gentex Corporation
Product code: Code HQG
Device class: Class 1
Regulation: 21 CFR 886.5844
Advisory panel: Ophthalmic
Date received: 1980-03-06
Decision date: 1980-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HQG

K935919 — SUNGLASSES1994-02-16
K920795 — 0R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEX1992-07-13
K900091 — MODIFIED OPHTHALMIC OPIR ONUFRYK IMAGE DEFLECTOR1990-04-04
K884360 — SEIKO P-6 PROGRESSIVE SPECTACLE LENSES1988-11-15
K882814 — NEOLENS PRESCRIPTION SPECTACLE LENS1988-07-29

More clearances from Gentex Corporation

K080117 — PATIENT ISOLATION UNIT, MODEL G019-10002009-01-30
K772024 — RX LENS SERIES1977-11-09

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