PEV — Dialysis Administration Kit Class II
FDA product code PEV covers "Dialysis Administration Kit", a Class II medical device regulated under 21 CFR 876.5820. Submissions are reviewed by the Gastroenterology, Urology panel.
Classification Details
- Product Code
- PEV
- Device Class
- Class II
- Regulation Number
- 876.5820
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.