Clearance Summary
FLEXT-THERM received FDA 510(k) clearance under submission number K781916, sponsored by E-Z-Em, 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 1979-02-02.
- Submission: K781916
- Applicant / Sponsor: E-Z-Em, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class III
- Regulation citation: 21 CFR 884.2982
- Decision date: 1979-02-02
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.