Clearance Summary
CT-COMPATIBLE FLETCHER SYSTEM APPLICATOR received FDA 510(k) clearance under submission number K903403, sponsored by University of Michigan. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1990-10-01.
- Submission: K903403
- Applicant / Sponsor: University of Michigan
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.5650
- Decision date: 1990-10-01
Classification & Regulation
This clearance is catalogued under FDA product code IWJ and 21 CFR 892.5650, within the Radiology review panel as a Class I device.