Clearance Summary
ELC-THERMO-SYSTEM received FDA 510(k) clearance under submission number K770678, sponsored by Cutter Laboratories, 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 1977-05-25.
- Submission: K770678
- Applicant / Sponsor: Cutter Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class III
- Regulation citation: 21 CFR 884.2982
- Decision date: 1977-05-25
Classification & Regulation
This clearance is catalogued under FDA product code KXZ and 21 CFR 884.2982, within the Obstetrics/Gynecology review panel as a Class III device.