Clearance Summary
SOMAS HUMAN SPINAL FLUID CONTROL received FDA 510(k) clearance under submission number K840974, sponsored by Somas Medical Industries, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1984-04-05.
- Submission: K840974
- Applicant / Sponsor: Somas Medical Industries, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class I
- Regulation citation: 21 CFR 866.5860
- Decision date: 1984-04-05
Classification & Regulation
This clearance is catalogued under FDA product code DFI and 21 CFR 866.5860, within the Immunology review panel as a Class I device.