Clearance Summary
CADD-TPN(TM) AMBULATORY INFUSION SYSTEM received FDA 510(k) clearance under submission number K931113, sponsored by Pharmacia Deltec, Inc.. 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 1994-04-28.
- Submission: K931113
- Applicant / Sponsor: Pharmacia Deltec, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 1994-04-28
Classification & Regulation
This clearance is catalogued under FDA product code FIH and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.