Clearance Summary
RADIO-PLAST received FDA 510(k) clearance under submission number K981115, sponsored by Smith & Nephew, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1998-06-25.
- Submission: K981115
- Applicant / Sponsor: Smith & Nephew, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 1998-06-25
Classification & Regulation
This clearance is catalogued under FDA product code LHN and 21 CFR 892.5050, within the Radiology review panel as a Class II device.