Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017654330

FEI Number

3017654330

Entity Name

AMERICAN BRANDS LLC

City/State/Country

Commerce Township, MI, US

Establishment Address

3250 Old Farm Lane, Suite 5, Commerce Township, MI 48390, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

American Brands LLC (Owner Number: 10079224)

Owner / Operator Contact Address

3250 Old Farm Lane, Suite 5, Commerce Township, MI 48390, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191643

PMA Number

N/A

All Registered Proprietary Names

Hypodermic Needle LL30gx1/2'', 100 Needle/Bx Hypodermic Needle LL25gx1.5'', 100 Needle/Bx Hypodermic Needle LL27gx3/4'', 100 Needle/Bx Hypodermic Needle LL25gx1'', 100 Needle/Bx Hypodermic Needle LL27gx1.5'', 100 Needle/Bx Hypodermic Needle LL18gx1'', 100 Needle/Bx Hypodermic Needle LL27gx1'', 100 Needle/Bx Hypodermic Needle LL20gx1'', 100 Needle/Bx Hypodermic Needle LL23gx1'', 100 Needle/Bx Hypodermic Needle LL22gx1'', 100 Needle/Bx Hypodermic Needle LL23gx1.5'', 100 Needle/Bx Hypodermic Needle LL25gx5/8'', 100 Needle/Bx

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2024-01-05

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

American Brands LLC

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
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

Similar Registrations

Registration Number	Establishment Name	Location
3027338968	RONCADELLE OPERATIONS SRL	Castel Mella Brescia, IT
3000214934	ALMAC PHARMA SERVICES LLC	Audubon, PA, US
3006850123	JAPAN IRRADIATION SERVICE CO., LTD	Naka-gun Ibaraki, JP
3029328631	PEGASUS IMPORTS	Houston, TX, US
3010621964	ATLAS MEDICAL PRODUCTS LLC	Hialeah, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017654330. Last updated year: 2026. Please use registration number 3017654330 when referencing this establishment in official correspondence.