Cleared Traditional

ENT TREATMENT UNITS

K822252 · Kelleher Corp. · Ear, Nose, Throat
Nov 1982
Decision
116d
Days
Class 1
Risk

About This 510(k) Submission

K822252 is an FDA 510(k) clearance for the ENT TREATMENT UNITS, a Unit, Examining/treatment, Ent (Class I — General Controls, product code ETF), submitted by Kelleher Corp. (Walker, US). The FDA issued a Cleared decision on November 22, 1982, 116 days after receiving the submission on July 29, 1982. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.5300.

Submission Details

510(k) Number K822252 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 1982
Decision Date November 22, 1982
Days to Decision 116 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary —

Device Classification

Product Code ETF — Unit, Examining/treatment, Ent
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.5300

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