Clearance Summary
dermaPACE System received FDA 510(k) clearance under submission number DEN160037, sponsored by Sanuwave, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2017-12-28.
- Submission: DEN160037
- Applicant / Sponsor: Sanuwave, Inc.
- Clearance pathway: Direct
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4685
- Decision date: 2017-12-28
Classification & Regulation
This clearance is catalogued under FDA product code PZL and 21 CFR 878.4685, within the General, Plastic Surgery review panel as a Class II device.