Clearance Summary
KERRISON RONGEURS received FDA 510(k) clearance under submission number K943583, sponsored by Enterprise Medical 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 1995-02-21.
- Submission: K943583
- Applicant / Sponsor: Enterprise Medical Corp.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4840
- Decision date: 1995-02-21
Classification & Regulation
This clearance is catalogued under FDA product code HAE and 21 CFR 882.4840, within the Neurology review panel as a Class II device.