BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    LOW PRESSURE BLOM-SINGER VOICE PROSTHES

    K Number: K823749 · Decision Jan 7, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    39
    Applicant Total
    50
    Review Days
    25

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    Basic Information

    Device Name
    LOW PRESSURE BLOM-SINGER VOICE PROSTHES
    K Number
    K823749
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3730
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Bivona Medical Technologies
    Date Received
    December 13, 1982
    Decision Date
    January 7, 1983
    Product Code
    EWL
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EWL Prosthesis, Laryngeal (Taub)

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