Cleared Traditional

RELIANCE TREATMENT CABINET

K843046 · F. & F. Koenigkramer · Ear, Nose, Throat
Sep 1984
Decision
56d
Days
Class 1
Risk

About This 510(k) Submission

K843046 is an FDA 510(k) clearance for the RELIANCE TREATMENT CABINET, a Unit, Examining/treatment, Ent (Class I — General Controls, product code ETF), submitted by F. & F. Koenigkramer (Mchenry, US). The FDA issued a Cleared decision on September 27, 1984, 56 days after receiving the submission on August 2, 1984. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.5300.

Submission Details

510(k) Number K843046 FDA.gov
FDA Decision Cleared SESE
Date Received August 02, 1984
Decision Date September 27, 1984
Days to Decision 56 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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