Clearance Summary
TUTOPLAST DURA received FDA 510(k) clearance under submission number K910555, sponsored by Pfrimmer-Viggo GmbH & Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1992-04-20.
- Submission: K910555
- Applicant / Sponsor: Pfrimmer-Viggo GmbH & Co.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5975
- Decision date: 1992-04-20
Classification & Regulation
This clearance is catalogued under FDA product code LEM and 21 CFR 882.5975, within the Neurology review panel as a Class II device.