Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3040314203

FEI Number

3040314203

Entity Name

LU MARK USA ENTERPRISES INC

City/State/Country

Brea, CA, US

Establishment Address

3301 Adelante St, Brea, CA 92823, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Lu Mark USA Enterprises Inc (Owner Number: 10095542)

Owner / Operator Contact Address

3301 Adelante St., Brea, CA 92823, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FZF	Splint, Extremity, Inflatable, External	General, Plastic Surgery	Class 1	878.3900	2026-05-11

Official Correspondent

Shine Lu

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Lu Mark USA Enterprises Inc

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3040314203. Last updated year: 2026. Please use registration number 3040314203 when referencing this establishment in official correspondence.