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

    MIZUHO RADIOLUCENT HEAD FRAME

    K Number: K955012 · Decision Sep 12, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    49
    Applicant Total
    5
    Review Days
    316

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    Basic Information

    Device Name
    MIZUHO RADIOLUCENT HEAD FRAME
    K Number
    K955012
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4460
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mizuho America, Inc.
    Date Received
    November 1, 1995
    Decision Date
    September 12, 1996
    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 Mizuho America, Inc.

    K Number Device Name
    K221524 Sugita AVM Microclip Applier
    K211183 Sugita AVM Microclips
    K990202 SUGITA TITANIUM ANEURYSM CLIP
    K960037 SUGITA AVM MICROCLIP