Clearance Summary
450/800 DRILL received FDA 510(k) clearance under submission number K812436, sponsored by Black & Decker(Tm). The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1981-11-02.
- Submission: K812436
- Applicant / Sponsor: Black & Decker(Tm)
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4360
- Decision date: 1981-11-02
Classification & Regulation
This clearance is catalogued under FDA product code HBC and 21 CFR 882.4360, within the Neurology review panel as a Class II device.