NUB — Colonic Irrigation System, General Well Being Class III
FDA product code NUB covers "Colonic Irrigation System, General Well Being", a Class III medical device regulated under 21 CFR 876.5220. Submissions are reviewed by the Gastroenterology, Urology panel.
Classification Details
- Product Code
- NUB
- Device Class
- Class III
- Regulation Number
- 876.5220
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
Call for PMAs on 12/26/96 per 61 FR 50707 on 9/27/96 - Colon cleansing for routine general well being