Clearance Summary
EASY-SPEC received FDA 510(k) clearance under submission number K790853, sponsored by C. 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 1979-07-30.
- Submission: K790853
- Applicant / Sponsor: C. Intl.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 1979-07-30
Classification & Regulation
This clearance is catalogued under FDA product code KNA and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.