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510(k) Data Aggregation

    K Number
    K971299
    Device Name
    SCIENTIFIC PLASTICS MODEL SP
    Manufacturer
    SCIENTIFIC PLASTICS, INC.
    Date Cleared
    1997-06-06

    (60 days)

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

    SCIENTIFIC PLASTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The indication for use of the air conduction hearing aid in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following categories : Severity : Slight , Mild , Moderate . . . . . . . Configuration : High Frequency Precipitously Sloping , Gradual Sloping Reverse Slope , Flat
    Device Description
    Air Conduction Hearing Aid. To amplify and transmit sound to the ear. Features: Volume Control. On/Off switch built into Volume Control. Assembly: Assembled from standard components which are widely utilized by other hearing aid manufacturers. Technical Characteristics: Technical specifications were obtained in accordance with S3.22-1987 ANSI Specifications. Preliminary data sheets for the SP models are enclosed. Fit: The frequency response of this product is dictated by the individual audiogram from each client. Power: Standard hearing aid battery #312.
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