Clearance Summary
KNIFE received FDA 510(k) clearance under submission number K854891, sponsored by Euro-Med Intl.. 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 1986-05-02.
- Submission: K854891
- Applicant / Sponsor: Euro-Med Intl.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1986-05-02
Classification & Regulation
This clearance is catalogued under FDA product code EMF and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.