Cleared Traditional

PAPPAS TRI-FLANGE VENTILATION TUBE

K895242 · Richards Medical Co., Inc. · Ear, Nose, Throat
Nov 1989
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K895242 is an FDA 510(k) clearance for the PAPPAS TRI-FLANGE VENTILATION TUBE, a Tube, Tympanostomy (Class II — Special Controls, product code ETD), submitted by Richards Medical Co., Inc. (Memphus, US). The FDA issued a Cleared decision on November 17, 1989, 88 days after receiving the submission on August 21, 1989. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3880.

Submission Details

510(k) Number K895242 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 1989
Decision Date November 17, 1989
Days to Decision 88 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary —

Device Classification

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

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