← Product Code [FZE](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZE) · K822130 # FRANCIS NASAL TUBE (K822130) _Tekna Med Corp. · FZE · Oct 13, 1982 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZE/K822130 ## Device Facts - **Applicant:** Tekna Med Corp. - **Product Code:** [FZE](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZE.md) - **Decision Date:** Oct 13, 1982 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.3680 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## Regulatory Identification A nose prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the nasal dorsum. --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZE/K822130](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZE/K822130) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite as:** FDA Device Explorer (Innolitics), https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FZE/K822130