Clearance Summary
PERCUSSION HAMMER received FDA 510(k) clearance under submission number K891571, sponsored by Sandal Surgico. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1989-03-31.
- Submission: K891571
- Applicant / Sponsor: Sandal Surgico
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class I
- Regulation citation: 21 CFR 882.1700
- Decision date: 1989-03-31
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.