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

    DELPORE SKIN CLOSURE

    K Number: K952947 · Decision Jul 24, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    34
    Applicant Total
    1
    Review Days
    28

    Basic Information

    Device Name
    DELPORE SKIN CLOSURE
    K Number
    K952947
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5240
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BITCO INTL.
    Date Received
    June 26, 1995
    Decision Date
    July 24, 1995
    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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