Clearance Summary
PHARMA-PLAST RECTAL TIP received FDA 510(k) clearance under submission number K843477, 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 1984-12-05.
- Submission: K843477
- Applicant / Sponsor: Zimmar Consulting , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1075
- Decision date: 1984-12-05
Classification & Regulation
This clearance is catalogued under FDA product code FCF and 21 CFR 876.1075, within the Gastroenterology, Urology review panel as a Class II device.