Clearance Summary
UTK-DTE AUTILARY SHIELD received FDA 510(k) clearance under submission number K954146, sponsored by Mallinckrodt Medical. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1995-12-06.
- Submission: K954146
- Applicant / Sponsor: Mallinckrodt Medical
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.6500
- Decision date: 1995-12-06
Classification & Regulation
This clearance is catalogued under FDA product code KPY and 21 CFR 892.6500, within the Radiology review panel as a Class I device.