Clearance Summary
NONCONDUCTIVE SHOE COVER received FDA 510(k) clearance under submission number K864026, sponsored by Kimberly-Clark 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 1986-10-30.
- Submission: K864026
- Applicant / Sponsor: Kimberly-Clark Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4040
- Decision date: 1986-10-30
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.