Clearance Summary
GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS received FDA 510(k) clearance under submission number K041501, sponsored by Guangzhou Fortunique , Ltd.. 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 2004-11-30.
- Submission: K041501
- Applicant / Sponsor: Guangzhou Fortunique , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4370
- Decision date: 2004-11-30
Classification & Regulation
This clearance is catalogued under FDA product code MMP and 21 CFR 878.4370, within the General, Plastic Surgery review panel as a Class II device.