Clearance Summary
FOXELL PLUS MULTIPLE(PERSONAL TOUCH), MODIFICATION received FDA 510(k) clearance under submission number K915105, sponsored by Wah-Chang and Stone Lion. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1992-03-27.
- Submission: K915105
- Applicant / Sponsor: Wah-Chang and Stone Lion
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 1992-03-27
Classification & Regulation
This clearance is catalogued under FDA product code LYY and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.