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

    SANO CLIP APPLIERS & REMOVERS

    K Number: K881912 · Decision Jun 6, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    13
    Applicant Total
    60
    Review Days
    28

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    Basic Information

    Device Name
    SANO CLIP APPLIERS & REMOVERS
    K Number
    K881912
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4175
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Downs Surgical , Ltd.
    Date Received
    May 9, 1988
    Decision Date
    June 6, 1988
    Product Code
    HCI
    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
    HCI Applier, Aneurysm Clip

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