Clearance Summary
SHAMPAINE RADI-OP MODEL 1700RC received FDA 510(k) clearance under submission number K860620, 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 1986-04-08.
- Submission: K860620
- Applicant / Sponsor: Smith & Nephew, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1980
- Decision date: 1986-04-08
Classification & Regulation
This clearance is catalogued under FDA product code KXJ and 21 CFR 892.1980, within the Radiology review panel as a Class II device.