Clearance Summary
ALBA HEALTH PAS WRAP SYSTEM received FDA 510(k) clearance under submission number K961405, sponsored by Alba-Waldensian, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1996-12-26.
- Submission: K961405
- Applicant / Sponsor: Alba-Waldensian, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5800
- Decision date: 1996-12-26
Classification & Regulation
This clearance is catalogued under FDA product code JOW and 21 CFR 870.5800, within the Cardiovascular review panel as a Class II device.