Clearance Summary
VAC FIX(R) SYSTEM received FDA 510(k) clearance under submission number K895697, sponsored by S&S Par Scientific. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1990-01-12.
- Submission: K895697
- Applicant / Sponsor: S&S Par Scientific
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 1990-01-12
Classification & Regulation
This clearance is catalogued under FDA product code IYE and 21 CFR 892.5050, within the Radiology review panel as a Class II device.