Clearance Summary
ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM received FDA 510(k) clearance under submission number K050433, sponsored by Zimmer Orthopaedic Surgical Products. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2005-04-13.
- Submission: K050433
- Applicant / Sponsor: Zimmer Orthopaedic Surgical Products
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2005-04-13
Classification & Regulation
This clearance is catalogued under FDA product code FRN and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.