Clearance Summary
NUNC IVF CENTERWELL AND ICSI DISHES received FDA 510(k) clearance under submission number K090429, sponsored by Thermo Fisher Scientific (Nalge Nunc Intl). 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 2009-09-18.
- Submission: K090429
- Applicant / Sponsor: Thermo Fisher Scientific (Nalge Nunc Intl)
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6160
- Decision date: 2009-09-18
Classification & Regulation
This clearance is catalogued under FDA product code MQK and 21 CFR 884.6160, within the Obstetrics/Gynecology review panel as a Class II device.