Clearance Summary
LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM received FDA 510(k) clearance under submission number K080158, sponsored by Lb Medical LLC. 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 2008-05-02.
- Submission: K080158
- Applicant / Sponsor: Lb Medical LLC
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 2008-05-02
Classification & Regulation
This clearance is catalogued under FDA product code FZW and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.