NII — Disinfectant, Dialysate Delivery System Class II
FDA product code NII covers "Disinfectant, Dialysate Delivery System", a Class II medical device regulated under 21 CFR 876.5860. Submissions are reviewed by the Gastroenterology, Urology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NII
- Device Class
- Class II
- Regulation Number
- 876.5860
- Submission Type
- Review Panel
- HO
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
Disinfectant intended for reprocessing dialysate delivery systems.