Clearance Summary
ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001 received FDA 510(k) clearance under submission number K020592, 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 2002-04-03.
- Submission: K020592
- Applicant / Sponsor: Alba-Waldensian, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5780
- Decision date: 2002-04-03
Classification & Regulation
This clearance is catalogued under FDA product code DWL and 21 CFR 880.5780, within the General Hospital review panel as a Class II device.