K252033
- 510(k) number
- K252033
- Device name
- Profoject Disposable Syringe, Profoject Disposable Syringe with Needle
- Applicant
- CMT Health PTE., Ltd. SG
- Product code
- FMF — Syringe, Piston
- Decision date
- 2025-07-25
- Date received
- 2025-06-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K252033.pdf
Official FDA record: K252033
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.