Clearance Summary
TAYLOR PERCUSSION HAMMER SS 410 OR 420 received FDA 510(k) clearance under submission number K852716, sponsored by The Huxley Instrument Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1985-07-26.
- Submission: K852716
- Applicant / Sponsor: The Huxley Instrument Corp.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class I
- Regulation citation: 21 CFR 882.1700
- Decision date: 1985-07-26
Classification & Regulation
This clearance is catalogued under FDA product code GWZ and 21 CFR 882.1700, within the Neurology review panel as a Class I device.