Cleared Traditional

VENTILATION TUBES W/ HYDROGEL COATING

K923353 · Microbio-Medics, Inc. · Ear, Nose, Throat
May 1993
Decision
314d
Days
Class 2
Risk

About This 510(k) Submission

K923353 is an FDA 510(k) clearance for the VENTILATION TUBES W/ HYDROGEL COATING, a Tube, Tympanostomy (Class II — Special Controls, product code ETD), submitted by Microbio-Medics, Inc. (Memphis, US). The FDA issued a Cleared decision on May 18, 1993, 314 days after receiving the submission on July 8, 1992. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3880.

Submission Details

510(k) Number K923353 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 1992
Decision Date May 18, 1993
Days to Decision 314 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code ETD — Tube, Tympanostomy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3880

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