Clearance Summary
CAST SHOE, CAST BOOT received FDA 510(k) clearance under submission number K830246, sponsored by Warm & Form, Orthopedic Materials. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1983-02-18.
- Submission: K830246
- Applicant / Sponsor: Warm & Form, Orthopedic Materials
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1360
- Decision date: 1983-02-18
Classification & Regulation
This clearance is catalogued under FDA product code JQB and 21 CFR 862.1360, within the Clinical Chemistry review panel as a Class I device.