Clearance Summary
MEDI PEN NEEDLE received FDA 510(k) clearance under submission number K131954, sponsored by Shanghai Carelife International Trading Co. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2014-05-29.
- Submission: K131954
- Applicant / Sponsor: Shanghai Carelife International Trading Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 2014-05-29
Classification & Regulation
This clearance is catalogued under FDA product code FMI and 21 CFR 880.5570, within the General Hospital review panel as a Class II device.