Clearance Summary
DISPOSABLE ISOLATION GOWN received FDA 510(k) clearance under submission number K911921, sponsored by Liaoning-Usa Corp.. 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 1991-05-13.
- Submission: K911921
- Applicant / Sponsor: Liaoning-Usa Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 1991-05-13
Classification & Regulation
This clearance is catalogued under FDA product code FYB and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class II device.