Clearance Summary
CLEANCUFF(TM) received FDA 510(k) clearance under submission number K931087, sponsored by Med-Con, 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 1993-05-27.
- Submission: K931087
- Applicant / Sponsor: Med-Con, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1120
- Decision date: 1993-05-27
Classification & Regulation
This clearance is catalogued under FDA product code DXQ and 21 CFR 870.1120, within the Cardiovascular review panel as a Class II device.