Clearance Summary
EMF PAL II MAIN GENERATOR AND IRRIGATION UNITS AND ACCESSORIES received FDA 510(k) clearance under submission number K062171, sponsored by Ortho Development Corp.. 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 2007-05-25.
- Submission: K062171
- Applicant / Sponsor: Ortho Development Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2007-05-25
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.