Clearance Summary
LIPOSAT (INFILTRATION PUMP), MODEL 00 002 274; VACUSAT (SUCTION UNIT), MODEL 00 002 252 (220 V), 00 002 318 (110 V); received FDA 510(k) clearance under submission number K053451, sponsored by Moeller Medical GmbH & Co. KG. 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 2006-08-25.
- Submission: K053451
- Applicant / Sponsor: Moeller Medical GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.5040
- Decision date: 2006-08-25
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.