BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    OMED WOUND CLOSURE STRIPS

    K Number: K874813 · Decision Jan 29, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    34
    Applicant Total
    6
    Review Days
    66

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    Basic Information

    Device Name
    OMED WOUND CLOSURE STRIPS
    K Number
    K874813
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5240
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Oxboro Medical Intl., Inc.
    Date Received
    November 24, 1987
    Decision Date
    January 29, 1988
    Product Code
    FPX
    Advisory Committee
    General Hospital
    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
    FPX Strip, Adhesive, Closure, Skin

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