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

    BA310 Abutment, BIA310 Implant/Abutment

    K Number: K182116 · Decision Dec 19, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    10
    Applicant Total
    20
    Review Days
    135

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    Basic Information

    Device Name
    BA310 Abutment, BIA310 Implant/Abutment
    K Number
    K182116
    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
    August 6, 2018
    Decision Date
    December 19, 2018
    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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