Clearance Summary
CART, PROCEDURES received FDA 510(k) clearance under submission number K770438, sponsored by I E Industries. 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 1977-07-01.
- Submission: K770438
- Applicant / Sponsor: I E Industries
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4900
- Decision date: 1977-07-01
Classification & Regulation
This clearance is catalogued under FDA product code HDD and 21 CFR 884.4900, within the Obstetrics/Gynecology review panel as a Class II device.