Clearance Summary
FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM received FDA 510(k) clearance under submission number K050575, sponsored by Futumeds Sdn Bhd. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2005-08-15.
- Submission: K050575
- Applicant / Sponsor: Futumeds Sdn Bhd
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 2005-08-15
Classification & Regulation
This clearance is catalogued under FDA product code MDM and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.