Clearance Summary
BREAST-MED TISSUE MARKER received FDA 510(k) clearance under submission number K133697, sponsored by Breast-Med, 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 2015-04-10.
- Submission: K133697
- Applicant / Sponsor: Breast-Med, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4300
- Decision date: 2015-04-10
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.