Clearance Summary
SINOVENT MAXILLARY SINUS DRAINAGE SYSTEM received FDA 510(k) clearance under submission number K896630, sponsored by Atos Medical AB. 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 1990-06-06.
- Submission: K896630
- Applicant / Sponsor: Atos Medical AB
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1990-06-06
Classification & Regulation
This clearance is catalogued under FDA product code KAM and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.