Clearance Summary
BAXTER D & C TRAY received FDA 510(k) clearance under submission number K901442, sponsored by Baxter Healthcare Corp. 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 1990-07-26.
- Submission: K901442
- Applicant / Sponsor: Baxter Healthcare Corp
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.4530
- Decision date: 1990-07-26
Classification & Regulation
This clearance is catalogued under FDA product code HCY and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class I device.