Cleared Traditional

TYMPANOSTOMY TUBES & VARIOUS TYPES

K822017 · Kelleher Corp. · Ear, Nose, Throat
Oct 1982
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K822017 is an FDA 510(k) clearance for the TYMPANOSTOMY TUBES & VARIOUS TYPES, a Tube, Tympanostomy (Class II — Special Controls, product code ETD), submitted by Kelleher Corp. (Walker, US). The FDA issued a Cleared decision on October 27, 1982, 111 days after receiving the submission on July 8, 1982. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3880.

Submission Details

510(k) Number K822017 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 1982
Decision Date October 27, 1982
Days to Decision 111 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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