Clearance Summary
SUNBURST, SUN SYSTEMS OR BC2 received FDA 510(k) clearance under submission number K801163, sponsored by Sun Ray Mfg., 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 1980-07-21.
- Submission: K801163
- Applicant / Sponsor: Sun Ray Mfg., Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4635
- Decision date: 1980-07-21
Classification & Regulation
This clearance is catalogued under FDA product code LEJ and 21 CFR 878.4635, within the General, Plastic Surgery review panel as a Class II device.