Clearance Summary
KMD-MARK1 TISSUE MARKER received FDA 510(k) clearance under submission number K093473, sponsored by Kent Medical Devices, 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 2010-07-02.
- Submission: K093473
- Applicant / Sponsor: Kent Medical Devices, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4300
- Decision date: 2010-07-02
Classification & Regulation
This clearance is catalogued under FDA product code NEU and 21 CFR 878.4300, within the General, Plastic Surgery review panel as a Class II device.