NNB — Needle, Reproduction, Assisted, Reprocessed Class II
FDA product code NNB covers "Needle, Reproduction, Assisted, Reprocessed", a Class II medical device regulated under 21 CFR 884.6100. Submissions are reviewed by the Obstetrics/Gynecology panel.
Classification Details
- Product Code
- NNB
- Device Class
- Class II
- Regulation Number
- 884.6100
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- 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).