THE CANAL (C.I.C.) AKA/HIDDEN EAR— 510(k) K941107

Name: FDA 510(k) clearance K941107
Creator: U.S. Food and Drug Administration
Published: 1994-08-09

Substantially Equivalent

Qualitone, Inc.

FDA 510(k) clearance K941107 for THE CANAL (C.I.C.) AKA/HIDDEN EAR, Substantially Equivalent on 1994-08-09. Applicant: Qualitone, Inc.. Device class: 1.

Clearance details

Applicant: Qualitone, Inc.
Product code: Code ESD
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1994-03-07
Decision date: 1994-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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