Clearance Summary
CAST CUTTER/CAST SAW/INSTRUMENT received FDA 510(k) clearance under submission number K820351, sponsored by Black & Decker(Tm). The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1982-03-02.
- Submission: K820351
- Applicant / Sponsor: Black & Decker(Tm)
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.5960
- Decision date: 1982-03-02
Classification & Regulation
This clearance is catalogued under FDA product code LGH and 21 CFR 888.5960, within the Orthopedic review panel as a Class I device.