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

    BA400 14mm Abutment

    K Number: K150555 · Decision Jul 15, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    10
    Applicant Total
    20
    Review Days
    133

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    Basic Information

    Device Name
    BA400 14mm Abutment
    K Number
    K150555
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3302
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cochlear Americas
    Date Received
    March 4, 2015
    Decision Date
    July 15, 2015
    Product Code
    MAH
    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
    MAH Hearing Aid, Bone Conduction, Implanted

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