Cleared Traditional

SILMED NASAL SEPTAL BUTTON

K013696 · Silmed, Inc. · Ear, Nose, Throat
Nov 2001
Decision
21d
Days
Risk

About This 510(k) Submission

K013696 is an FDA 510(k) clearance for the SILMED NASAL SEPTAL BUTTON, a Button, Nasal Septal, submitted by Silmed, Inc. (Leesburg,, US). The FDA issued a Cleared decision on November 28, 2001, 21 days after receiving the submission on November 7, 2001. This device falls under the Ear, Nose, Throat review panel.

Submission Details

510(k) Number K013696 FDA.gov
FDA Decision Cleared SESE
Date Received November 07, 2001
Decision Date November 28, 2001
Days to Decision 21 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code LFB — Button, Nasal Septal
Device Class