Clearance Summary
DERMASTREAM received FDA 510(k) clearance under submission number K060046, sponsored by Enzysurge , Ltd.. 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 2006-02-27.
- Submission: K060046
- Applicant / Sponsor: Enzysurge , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4020
- Decision date: 2006-02-27
Classification & Regulation
This clearance is catalogued under FDA product code NAD and 21 CFR 878.4020, within the General, Plastic Surgery review panel as a Class I device.