Clearance Summary
BLACKSTAR(TM) STAR SYSTEM received FDA 510(k) clearance under submission number K945659, sponsored by Xomed-Treace, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 1995-01-09.
- Submission: K945659
- Applicant / Sponsor: Xomed-Treace, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4250
- Decision date: 1995-01-09
Classification & Regulation
This clearance is catalogued under FDA product code ERL and 21 CFR 874.4250, within the Ear, Nose, Throat review panel as a Class II device.