Clearance Summary
PS MEDICAL CSF-ACCESS DEVICE received FDA 510(k) clearance under submission number K913412, sponsored by Pudenz-Schulte Medical Research Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1993-03-30.
- Submission: K913412
- Applicant / Sponsor: Pudenz-Schulte Medical Research Corp.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5550
- Decision date: 1993-03-30
Classification & Regulation
This clearance is catalogued under FDA product code JXG and 21 CFR 882.5550, within the Neurology review panel as a Class II device.