NMP — Needle, Isotope, Reprocessed Class II
FDA product code NMP covers "Needle, Isotope, Reprocessed", a Class II medical device regulated under 21 CFR 892.5730. Submissions are reviewed by the Radiology panel.
Classification Details
- Product Code
- NMP
- Device Class
- Class II
- Regulation Number
- 892.5730
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- 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).