Clearance Summary
BRIGHTSTAR received FDA 510(k) clearance under submission number K981081, sponsored by Hill-Rom, 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 1998-04-29.
- Submission: K981081
- Applicant / Sponsor: Hill-Rom, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4580
- Decision date: 1998-04-29
Classification & Regulation
This clearance is catalogued under FDA product code FSY and 21 CFR 878.4580, within the General, Plastic Surgery review panel as a Class II device.