Clearance Summary
C-SECTION TRAY received FDA 510(k) clearance under submission number K940518, sponsored by Cush Medical Products. 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 1994-08-18.
- Submission: K940518
- Applicant / Sponsor: Cush Medical Products
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 1994-08-18
Classification & Regulation
This clearance is catalogued under FDA product code MLS and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.