Clearance Summary
OREX SHOE COVERS received FDA 510(k) clearance under submission number K943034, sponsored by Thantex Specialties, 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 1995-01-02.
- Submission: K943034
- Applicant / Sponsor: Thantex Specialties, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4040
- Decision date: 1995-01-02
Classification & Regulation
This clearance is catalogued under FDA product code FXP and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class I device.