Cleared Traditional

HYDROFERA BACTERISTATIC NASAL DRESSING

K983276 · Hydrofera, LLC · Ear, Nose, Throat
Sep 1999
Decision
362d
Days
Class 1
Risk

About This 510(k) Submission

K983276 is an FDA 510(k) clearance for the HYDROFERA BACTERISTATIC NASAL DRESSING, a Balloon, Epistaxis (Class I — General Controls, product code EMX), submitted by Hydrofera, LLC (Willimantic, US). The FDA issued a Cleared decision on September 14, 1999, 362 days after receiving the submission on September 17, 1998. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4100.

Submission Details

510(k) Number K983276 FDA.gov
FDA Decision Cleared SESE
Date Received September 17, 1998
Decision Date September 14, 1999
Days to Decision 362 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement

Device Classification

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

Similar Devices — EMX Balloon, Epistaxis

All 46
PosiSep X BAM Hemostat Dressing/Intranasal Splint
K220326 · Hemostasis, LLC · Nov 2022
NASALCEASE
K041446 · Les Laboratorires Brothier, S.A. · Jul 2004
RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100
K000108 · Bhk Holding · May 2000
HYLASINE
K993362 · Biomatrix, Inc. · Mar 2000
MEROGEL NASAL DRESSING AND SINUS STENT
K982731 · Xomed, Inc. · Feb 1999
ENTAXIS NASAL PACKING
K984069 · Les Laboratorires Brothier, S.A. · Jan 1999