Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002806821

FEI Number

3002806821

Entity Name

N.V. Organon

City/State/Country

Oss Noord-Brabant, NL

Establishment Address

Kloosterstraat 6, Oss Noord-Brabant 5349 AB, NL

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Organon LLC (Owner Number: 10082609)

Owner / Operator Contact Address

30 Hudson Street, Jersey City, NJ 07302, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K162516

PMA Number

N/A

All Registered Proprietary Names

FOLLISTIM PEN & Pen Needles

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	2023-10-17

Official Correspondent

Suraj Ramachandran

US Agent Details

Suraj Ramachandran Business: Organon LLC Email: francisco.haro@organon.com Phone: (551) 4306231

Related Public Records

Same Entity

Organon LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3017425145	Organon LLC	Jersey City, NJ, US

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

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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 3002806821. Last updated year: 2026. Please use registration number 3002806821 when referencing this establishment in official correspondence.