Clearance Summary
ENVELA (HYDROHESIVE OCCLUSIVE DRESSING) received FDA 510(k) clearance under submission number K072560, sponsored by Teikoku Pharma USA, Inc.. 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 2008-06-17.
- Submission: K072560
- Applicant / Sponsor: Teikoku Pharma USA, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4020
- Decision date: 2008-06-17
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.