Clearance Summary
SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M received FDA 510(k) clearance under submission number K910783, sponsored by Smith & Nephew Equipment Group. 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 1991-04-02.
- Submission: K910783
- Applicant / Sponsor: Smith & Nephew Equipment Group
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4950
- Decision date: 1991-04-02
Classification & Regulation
This clearance is catalogued under FDA product code BWN and 21 CFR 878.4950, within the General, Plastic Surgery review panel as a Class I device.