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

    MALCOLM-RAND MICRONEUROSURGICAL CRANIO-XRAY FRAME

    K Number: K874298 · Decision Feb 4, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    49
    Applicant Total
    2
    Review Days
    107

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    Basic Information

    Device Name
    MALCOLM-RAND MICRONEUROSURGICAL CRANIO-XRAY FRAME
    K Number
    K874298
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4460
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Engineered Orthopedic Technologies, Inc.
    Date Received
    October 20, 1987
    Decision Date
    February 4, 1988
    Product Code
    HBL
    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
    HBL Holder, Head, Neurosurgical (Skull Clamp)

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    Other Clearances by Engineered Orthopedic Technologies, Inc.

    K Number Device Name
    K942747 MALCOLM-LYNN(TM) EOT SUCTION REG VALVE(TM) (SRV) )