Clearance Summary
LIPOSAT BASIC (INFILTRATION PUMP), MODEL 92-007 688 received FDA 510(k) clearance under submission number K072793, sponsored by Moeller Medical GmbH & Co. KG. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2008-03-04.
- Submission: K072793
- Applicant / Sponsor: Moeller Medical GmbH & Co. KG
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.5040
- Decision date: 2008-03-04
Classification & Regulation
This clearance is catalogued under FDA product code QPB and 21 CFR 878.5040, within the General, Plastic Surgery review panel as a Class II device.