Clearance Summary
LIPISYSTEMS AQUAVAGE, MODELS AV2000 AND AV1200 received FDA 510(k) clearance under submission number K092284, sponsored by Medical Device Resource Corp.. 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 2009-09-01.
- Submission: K092284
- Applicant / Sponsor: Medical Device Resource Corp.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.5040
- Decision date: 2009-09-01
Classification & Regulation
This clearance is catalogued under FDA product code MUU and 21 CFR 878.5040, within the General, Plastic Surgery review panel as a Class II device.