NKK — Needle, Hypodermic, Single Lumen, Reprocessed Class II
FDA product code NKK covers "Needle, Hypodermic, Single Lumen, Reprocessed", a Class II medical device regulated under 21 CFR 880.5570. Submissions are reviewed by the General Hospital panel.
Classification Details
- Product Code
- NKK
- Device Class
- Class II
- Regulation Number
- 880.5570
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- 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).