Clearance Summary
PHARMA-PLAST URINARY DRAINAGE BAG 2000 received FDA 510(k) clearance under submission number K843480, sponsored by Zimmar Consulting , Ltd.. 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 1984-10-11.
- Submission: K843480
- Applicant / Sponsor: Zimmar Consulting , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5250
- Decision date: 1984-10-11
Classification & Regulation
This clearance is catalogued under FDA product code KNX and 21 CFR 876.5250, within the Gastroenterology, Urology review panel as a Class II device.