UNITRON MODEL SOUND F/X— 510(k) K954430

Name: FDA 510(k) clearance K954430
Creator: U.S. Food and Drug Administration
Published: 1995-10-06

Substantially Equivalent

Unitron Industries, Inc.

FDA 510(k) clearance K954430 for UNITRON MODEL SOUND F/X, Substantially Equivalent on 1995-10-06. Applicant: Unitron Industries, Inc.. Device class: 1.

Clearance details

Applicant: Unitron Industries, Inc.
Product code: Code ESD
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1995-09-22
Decision date: 1995-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Huron, MI, US

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