Clearance Summary
SURGICAL BUR received FDA 510(k) clearance under submission number K943758, sponsored by Komet Medical. 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 1994-08-22.
- Submission: K943758
- Applicant / Sponsor: Komet Medical
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4820
- Decision date: 1994-08-22
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.