Clearance Summary
ULTRA-LINE RONGEUR received FDA 510(k) clearance under submission number K943635, sponsored by V. Mueller Neuro/Spine. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1994-12-07.
- Submission: K943635
- Applicant / Sponsor: V. Mueller Neuro/Spine
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4840
- Decision date: 1994-12-07
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.