K241476
- 510(k) number
- K241476
- Device name
- ToxiSeal Vial Adaptor with External Flip Balloon
- Applicant
- Epic Medical Pte. , Ltd. SG
- Product code
- ONB — Closed Antineoplastic And Hazardous Drug Reconstitut
- Decision date
- 2024-06-21
- Date received
- 2024-05-24
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
510(k) Summary (official FDA PDF): K241476.pdf
Official FDA record: K241476
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.