Clearance Summary
KOMET SURGICAL BUR received FDA 510(k) clearance under submission number K883255, sponsored by Komet Medical, Div. of Brasseler USA I, L.P.. 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 1988-09-15.
- Submission: K883255
- Applicant / Sponsor: Komet Medical, Div. of Brasseler USA I, L.P.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4820
- Decision date: 1988-09-15
Classification & Regulation
This clearance is catalogued under FDA product code GFF and 21 CFR 878.4820, within the General, Plastic Surgery review panel as a Class I device.