Cleared Traditional

K982667 - MICROMEDICS NASAL SEPTAL BUTTON (FDA 510(k) Clearance)

K982667 · Micromedics, Inc. · Ear, Nose, Throat device

Nov 1998

Decision

116d

Days

—

Risk

K982667 is an FDA 510(k) clearance for the MICROMEDICS NASAL SEPTAL BUTTON. This device is classified as a Button, Nasal Septal.

Submitted by Micromedics, Inc. (Eagan, US). The FDA issued a Cleared decision on November 24, 1998, 116 days after receiving the submission on July 31, 1998.

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

Submission Details

510(k) Number	K982667 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 31, 1998
Decision Date	November 24, 1998
Days to Decision	116 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement

Device Classification

Product Code	LFB — Button, Nasal Septal
Device Class	—