Clearance Summary
TRILICON BREASE PROSTHESIS DIFFERENT received FDA 510(k) clearance under submission number K841171, sponsored by Baurs Krey Assoc., 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 1984-04-25.
- Submission: K841171
- Applicant / Sponsor: Baurs Krey Assoc., Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.3800
- Decision date: 1984-04-25
Classification & Regulation
This clearance is catalogued under FDA product code GBI and 21 CFR 878.3800, within the General, Plastic Surgery review panel as a Class I device.