Clearance Summary
JSA'S REPROCESSED COMPRESSION SLEEVE DEVICES received FDA 510(k) clearance under submission number K040065, sponsored by Jack Speer and Assoc., 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 2004-03-29.
- Submission: K040065
- Applicant / Sponsor: Jack Speer and Assoc., Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5800
- Decision date: 2004-03-29
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.