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

    Codman Surgical Patties & Strips

    K Number: K193346 · Decision Nov 20, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    23
    Applicant Total
    13
    Review Days
    353

    Basic Information

    Device Name
    Codman Surgical Patties & Strips
    K Number
    K193346
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4700
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Integra LifeSciences Corporation
    Date Received
    December 3, 2019
    Decision Date
    November 20, 2020
    Product Code
    HBA
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HBA Neurosurgical Paddie

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