Clearance Summary
LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE, MODEL ZLK-100 received FDA 510(k) clearance under submission number K083455, sponsored by Medi-Khan USA, Inc.. 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 2009-05-18.
- Submission: K083455
- Applicant / Sponsor: Medi-Khan USA, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.5040
- Decision date: 2009-05-18
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.