K242632
- 510(k) number
- K242632
- Device name
- Verifine® Pen Needles
- Applicant
- Promisemed Hangzhou Meditech Co., Ltd. CN
- Product code
- FMI — Needle, Hypodermic, Single Lumen
- Decision date
- 2024-09-26
- Date received
- 2024-09-03
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K242632.pdf
Official FDA record: K242632
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.