Clearance Summary
BABYLANCE HEEL INCISION DEVICE received FDA 510(k) clearance under submission number K130132, sponsored by Medipurpose Pte. , Ltd.. 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 2013-02-11.
- Submission: K130132
- Applicant / Sponsor: Medipurpose Pte. , Ltd.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4850
- Decision date: 2013-02-11
Classification & Regulation
This clearance is catalogued under FDA product code FMK and 21 CFR 878.4850, within the General, Plastic Surgery review panel as a Class II device.