Clearance Summary
ROSSITER SINUS STENT received FDA 510(k) clearance under submission number K951803, sponsored by Smith & Nephew Richards, 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 1995-05-11.
- Submission: K951803
- Applicant / Sponsor: Smith & Nephew Richards, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1995-05-11
Classification & Regulation
This clearance is catalogued under FDA product code KAM and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.