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

    SHELHIGH NO-REACT DURA SHIELD

    K Number: K982101 · Decision May 2, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    42
    Applicant Total
    8
    Review Days
    687

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    Basic Information

    Device Name
    SHELHIGH NO-REACT DURA SHIELD
    K Number
    K982101
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5910
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shelhigh, Inc.
    Date Received
    June 15, 1998
    Decision Date
    May 2, 2000
    Product Code
    GXQ
    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
    GXQ Dura Substitute

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    Other Clearances by Shelhigh, Inc.

    K Number Device Name
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    K982810 SHELHIGH NO-REACT VASCUPATCH
    K981756 SHELHIGH NO-REACT PNEUMOPLEDGETS
    K974914 SHELHIGH NO-REACT PERICARDIAL PATCHES
    K964467 SHELHIGH PERICARDIAL PATCH