Clearance Summary
150 DRIVER/REAMER received FDA 510(k) clearance under submission number K800312, sponsored by Black & Decker(Tm). 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 1980-02-22.
- Submission: K800312
- Applicant / Sponsor: Black & Decker(Tm)
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4820
- Decision date: 1980-02-22
Classification & Regulation
This clearance is catalogued under FDA product code KIJ and 21 CFR 878.4820, within the General, Plastic Surgery review panel as a Class I device.