Clearance Summary
SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY received FDA 510(k) clearance under submission number K955174, sponsored by Sodem Diffusion SA. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1996-01-22.
- Submission: K955174
- Applicant / Sponsor: Sodem Diffusion SA
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4820
- Decision date: 1996-01-22
Classification & Regulation
This clearance is catalogued under FDA product code GET and 21 CFR 878.4820, within the General, Plastic Surgery review panel as a Class I device.