Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009405889

FEI Number

3009405889

Entity Name

EYEWEAR DISTRIBUTORS INC.

City/State/Country

Miami, FL, US

Establishment Address

4829 NW 72nd Ave, Miami, FL 33166, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Eyewear distributors inc. (Owner Number: 10041896)

Owner / Operator Contact Address

4829 nw 72 ave, Miami, FL 33166, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Vanba OGO Medical Instruments SEBASTIAN STEFANO BLUE OPTICS LENS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-04-12
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2015-02-03
HQG	Lens, Spectacle, Non-Custom (Prescription)	Ophthalmic	Class 1	886.5844	2017-01-12

Official Correspondent

Paige Ujueta

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Eyewear distributors inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K910951	United Optical, Spa	OPTHLAMIC FRAMES	1991-05-06

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3016871880	PRIMEX DESIGN & FABRICATION	Richmond, IN, US
3005360866	QEL DOMINICANA S.A.	ESPERANZA Valverde, DO
3010601984	Jiangsu Haize Medical Scientific Development Co.,Ltd.	Wuxi Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009405889. Last updated year: 2026. Please use registration number 3009405889 when referencing this establishment in official correspondence.