Clearance Summary
LIQUIBAND ULTIMA, MODEL LB0004 received FDA 510(k) clearance under submission number K083531, sponsored by Medlogic Global , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2009-02-12.
- Submission: K083531
- Applicant / Sponsor: Medlogic Global , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4010
- Decision date: 2009-02-12
Classification & Regulation
This clearance is catalogued under FDA product code MPN and 21 CFR 878.4010, within the General, Plastic Surgery review panel as a Class II device.