Clearance Summary
3.5 MM SIDE EFFECT ELECTRODE WITH INTEGRATED HANDPIECE, MODEL 227301, 3.5 MM ANGLED SIDE EFFECT ELECTRODE WITH INTEGRATE received FDA 510(k) clearance under submission number K082643, sponsored by Depuy Mitek, A Johnson & Johnson Company. 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 2008-12-19.
- Submission: K082643
- Applicant / Sponsor: Depuy Mitek, A Johnson & Johnson Company
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2008-12-19
Classification & Regulation
This clearance is catalogued under FDA product code GEI and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.