Clearance Summary
CELLERATION MIST THERAPY SYSTEM received FDA 510(k) clearance under submission number DEN040004, sponsored by Celleration. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2004-06-25.
- Submission: DEN040004
- Applicant / Sponsor: Celleration
- Clearance pathway: Post-NSE
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4410
- Decision date: 2004-06-25
Classification & Regulation
This clearance is catalogued under FDA product code NRB and 21 CFR 878.4410, within the General, Plastic Surgery review panel as a Class II device.