NNG — Set, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed Class II
FDA product code NNG covers "Set, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed", a Class II medical device regulated under 21 CFR 876.5820. Submissions are reviewed by the Gastroenterology, Urology panel.
Classification Details
- Product Code
- NNG
- Device Class
- Class II
- Regulation Number
- 876.5820
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).