Cleared Traditional

NASALCEASE

K041446 · Les Laboratorires Brothier, S.A. · Ear, Nose, Throat
Jul 2004
Decision
30d
Days
Class 1
Risk

About This 510(k) Submission

K041446 is an FDA 510(k) clearance for the NASALCEASE, a Balloon, Epistaxis (Class I — General Controls, product code EMX), submitted by Les Laboratorires Brothier, S.A. (Nanterre Paris, FR). The FDA issued a Cleared decision on July 1, 2004, 30 days after receiving the submission on June 1, 2004. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4100.

Submission Details

510(k) Number K041446 FDA.gov
FDA Decision Cleared SESE
Date Received June 01, 2004
Decision Date July 01, 2004
Days to Decision 30 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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