Clearance Summary
FLEXI-THERM FILM received FDA 510(k) clearance under submission number K770986, 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 1977-09-12.
- Submission: K770986
- 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: 1977-09-12
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.