Clearance Summary
CPR D & C TRAY received FDA 510(k) clearance under submission number K960239, sponsored by Custom Pack Reliability. 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 1996-05-23.
- Submission: K960239
- Applicant / Sponsor: Custom Pack Reliability
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1175
- Decision date: 1996-05-23
Classification & Regulation
This clearance is catalogued under FDA product code HHK and 21 CFR 884.1175, within the Obstetrics/Gynecology review panel as a Class II device.