Clearance Summary
SPECIAL RONGEUR received FDA 510(k) clearance under submission number K903401, sponsored by Sur-Med Instruments, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1990-08-10.
- Submission: K903401
- Applicant / Sponsor: Sur-Med Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4840
- Decision date: 1990-08-10
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.