Cleared Traditional

ENTAXIS NASAL PACKING

K984069 · Les Laboratorires Brothier, S.A. · Ear, Nose, Throat
Jan 1999
Decision
70d
Days
Class 1
Risk

About This 510(k) Submission

K984069 is an FDA 510(k) clearance for the ENTAXIS NASAL PACKING, a Balloon, Epistaxis (Class I — General Controls, product code EMX), submitted by Les Laboratorires Brothier, S.A. (St Louis, US). The FDA issued a Cleared decision on January 25, 1999, 70 days after receiving the submission on November 16, 1998. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4100.

Submission Details

510(k) Number K984069 FDA.gov
FDA Decision Cleared SESE
Date Received November 16, 1998
Decision Date January 25, 1999
Days to Decision 70 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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