Clearance Summary
THERMO FORMA, CRYOMED, CONTROLLED RATE FREEZERS; MODELS # 7456, 7457, 7458,7459,7475,7476 received FDA 510(k) clearance under submission number K021042, sponsored by Thermo Forma, Inc.. 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 2002-05-15.
- Submission: K021042
- Applicant / Sponsor: Thermo Forma, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6120
- Decision date: 2002-05-15
Classification & Regulation
This clearance is catalogued under FDA product code MQG and 21 CFR 884.6120, within the Obstetrics/Gynecology review panel as a Class II device.