Clearance Summary
HEEL/ELBOW PROTECTOR received FDA 510(k) clearance under submission number K771913, sponsored by Alba-Waldensian, Inc.. 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 1977-11-15.
- Submission: K771913
- Applicant / Sponsor: Alba-Waldensian, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6450
- Decision date: 1977-11-15
Classification & Regulation
This clearance is catalogued under FDA product code FMP and 21 CFR 880.6450, within the General Hospital review panel as a Class I device.