Cleared Traditional

MEROGEL NASAL DRESSING AND SINUS STENT

K982731 · Xomed, Inc. · Ear, Nose, Throat
Feb 1999
Decision
181d
Days
Class 1
Risk

About This 510(k) Submission

K982731 is an FDA 510(k) clearance for the MEROGEL NASAL DRESSING AND SINUS STENT, a Balloon, Epistaxis (Class I — General Controls, product code EMX), submitted by Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on February 2, 1999, 181 days after receiving the submission on August 5, 1998. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4100.

Submission Details

510(k) Number K982731 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 1998
Decision Date February 02, 1999
Days to Decision 181 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code EMX — Balloon, Epistaxis
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.4100

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