Clearance Summary
WANDY DISPERSVIE ELECTRODE received FDA 510(k) clearance under submission number K121268, sponsored by Bio-Med 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 2012-12-20.
- Submission: K121268
- Applicant / Sponsor: Bio-Med USA, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2012-12-20
Classification & Regulation
This clearance is catalogued under FDA product code ODR and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.