Clearance Summary
RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAY received FDA 510(k) clearance under submission number K955683, sponsored by Contour Fabricators of Florida, 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 1996-02-01.
- Submission: K955683
- Applicant / Sponsor: Contour Fabricators of Florida, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1996-02-01
Classification & Regulation
This clearance is catalogued under FDA product code MJG and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.