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510(k) Data Aggregation

    K Number
    K973846
    Device Name
    AIR CONDUCTION HEARING AID
    Date Cleared
    1997-10-29

    (21 days)

    Product Code
    Regulation Number
    874.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    BARON TRADING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A. General: The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following catage(fes). (Check appropriate space(s)): Severity: Mild, Moderate. Configuration: Flat. B. Specific (List Claims): Not Found
    Device Description
    AIR CONDUCTION HEARING AID (BC-H2000)
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