Clearance Summary
STERILE ORTHOPEDIC STOCKINETTE received FDA 510(k) clearance under submission number K812904, sponsored by Alba Health Care. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1982-01-18.
- Submission: K812904
- Applicant / Sponsor: Alba Health Care
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.5940
- Decision date: 1982-01-18
Classification & Regulation
This clearance is catalogued under FDA product code LGF and 21 CFR 888.5940, within the Orthopedic review panel as a Class I device.