Clearance Summary
RELIANCE MODEL 200 PODIATRY CHAIR received FDA 510(k) clearance under submission number K860519, sponsored by F. & F. Koenigkramer. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1986-02-19.
- Submission: K860519
- Applicant / Sponsor: F. & F. Koenigkramer
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4960
- Decision date: 1986-02-19
Classification & Regulation
This clearance is catalogued under FDA product code LGX and 21 CFR 878.4960, within the General, Plastic Surgery review panel as a Class I device.