FDA Registration
Active
🇳🇱 Netherlands
FOLLISTIM Cartridge & Needles, FOLLISTIM PEN & Needle Starter Kit
Reg #: 3002806821
·
FEI: 3002806821
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- N.V. Organon
- Registration Number
- 3002806821
- FEI Number
- 3002806821
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Kloosterstraat 6
- City
- Oss Noord-Brabant
- Country
- NL
Regulatory Submissions
- 510(k) Number
- K162516
Owner / Operator
- Firm Name
- Organon LLC
- Operator Number
- 10082609
- Address
- 30 Hudson Street
- City
- Jersey City
- State
- NJ
- Postal Code
- 07302
- Country
- US
- Correspondent
- Francisco Haro
US Agent
- Business Name
- Organon LLC
- Contact Name
- Francisco Haro
- Address
- 30 Hudson St
- City
- Jersey City
- State
- NJ
- ZIP
- 07302
- Country
- US
- [email protected]
- Phone
- 908 7407073
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2023-10-17 |
Proprietary Names
FOLLISTIM Cartridge & Needles, FOLLISTIM PEN & Needle Starter Kit
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility