Clearance Summary
VITRIFREEZE MEDIUM; VITRITHAW MEDIUM received FDA 510(k) clearance under submission number K070135, sponsored by Fertipro NV. 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 2007-08-16.
- Submission: K070135
- Applicant / Sponsor: Fertipro NV
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6180
- Decision date: 2007-08-16
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.