Clearance Summary
RAYLOR FUSION FUNNEL received FDA 510(k) clearance under submission number K872281, sponsored by Cedar Surgical, Inc.. 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 1987-11-02.
- Submission: K872281
- Applicant / Sponsor: Cedar Surgical, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1987-11-02
Classification & Regulation
This clearance is catalogued under FDA product code HXR and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.