Clearance Summary
SIALO DRAIN received FDA 510(k) clearance under submission number K072334, sponsored by Sialo Technology, 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 2008-07-18.
- Submission: K072334
- Applicant / Sponsor: Sialo Technology, Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4200
- Decision date: 2008-07-18
Classification & Regulation
This clearance is catalogued under FDA product code OAJ and 21 CFR 878.4200, within the General, Plastic Surgery review panel as a Class I device.