NLB — Trocar, Tracheal, Laryngeal, Sinus, Reprocessed Class I
FDA product code NLB covers "Trocar, Tracheal, Laryngeal, Sinus, Reprocessed", a Class I medical device regulated under 21 CFR 874.4420. Submissions are reviewed by the Ear, Nose, Throat panel.
Classification Details
- Product Code
- NLB
- Device Class
- Class I
- Regulation Number
- 874.4420
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
Definition
Same as KBG, KAB, and KCI but need one code for reprocessing. 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).