BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇱 Israel

    WISEBANDS SKIN CLOSURE DEVICE

    K Number: K002315 · Decision Mar 15, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    227

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    Basic Information

    Device Name
    WISEBANDS SKIN CLOSURE DEVICE
    K Number
    K002315
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4320
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wisebands , Ltd.
    Date Received
    July 31, 2000
    Decision Date
    March 15, 2001
    Product Code
    MKY
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MKY System, Skin Closure

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