Clearance Summary
BME BONE DRILL BITS received FDA 510(k) clearance under submission number K964073, sponsored by Biomedical Ent., 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 1996-11-14.
- Submission: K964073
- Applicant / Sponsor: Biomedical Ent., Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4820
- Decision date: 1996-11-14
Classification & Regulation
This clearance is catalogued under FDA product code GEY and 21 CFR 878.4820, within the General, Plastic Surgery review panel as a Class I device.