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

    NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES

    K Number: K073576 · Decision Feb 22, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    23
    Applicant Total
    1
    Review Days
    65

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    Basic Information

    Device Name
    NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES
    K Number
    K073576
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4700
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Harod Enterprises, Inc.
    Date Received
    December 19, 2007
    Decision Date
    February 22, 2008
    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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