Cleared Traditional

K871200 - CUI NASAL SEPTUM BUTTON
(FDA 510(k) Clearance)

Apr 1987
Decision
21d
Days
Risk

K871200 is an FDA 510(k) clearance for the CUI NASAL SEPTUM BUTTON. This device is classified as a Button, Nasal Septal.

Submitted by Cox-Uphuff Intl. (Carpinteria, US). The FDA issued a Cleared decision on April 15, 1987, 21 days after receiving the submission on March 25, 1987.

This device falls under the Ear, Nose, Throat FDA review panel.

Submission Details

510(k) Number K871200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1987
Decision Date April 15, 1987
Days to Decision 21 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary

Device Classification

Product Code LFB — Button, Nasal Septal
Device Class