Clearance Summary
OVOIL-150, MODEL 5002 received FDA 510(k) clearance under submission number K991351, sponsored by Vitrolife Sweden AB. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2000-02-25.
- Submission: K991351
- Applicant / Sponsor: Vitrolife Sweden AB
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6180
- Decision date: 2000-02-25
Classification & Regulation
This clearance is catalogued under FDA product code MQL and 21 CFR 884.6180, within the Obstetrics/Gynecology review panel as a Class II device.