Clearance Summary
BREAST STABILIZER received FDA 510(k) clearance under submission number K925874, sponsored by Bip USA, 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 1993-03-16.
- Submission: K925874
- Applicant / Sponsor: Bip USA, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1993-03-16
Classification & Regulation
This clearance is catalogued under FDA product code MDM and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.