Clearance Summary
CPR URINE BAG received FDA 510(k) clearance under submission number K960217, sponsored by Custom Pack Reliability. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1996-03-28.
- Submission: K960217
- Applicant / Sponsor: Custom Pack Reliability
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5250
- Decision date: 1996-03-28
Classification & Regulation
This clearance is catalogued under FDA product code FAQ and 21 CFR 876.5250, within the Gastroenterology, Urology review panel as a Class I device.