Clearance Summary
KUT-SHIELD received FDA 510(k) clearance under submission number K895092, sponsored by Kut-Guard, 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 1989-09-26.
- Submission: K895092
- Applicant / Sponsor: Kut-Guard, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.3910
- Decision date: 1989-09-26
Classification & Regulation
This clearance is catalogued under FDA product code FYH and 21 CFR 878.3910, within the General, Plastic Surgery review panel as a Class I device.