K240961
- 510(k) number
- K240961
- Device name
- Disposable Pen Injector Assembly
- Applicant
- Wuxi Nest Biotechnology Co., Ltd. CN
- Product code
- FMF — Syringe, Piston
- Decision date
- 2024-08-15
- Date received
- 2024-04-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K240961.pdf
Official FDA record: K240961
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.