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

    QUALTEX SKIN STAPLE EXTRACTOR

    K Number: K911204 · Decision May 8, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    104
    Registration Numbers
    104
    Same Product Code
    18
    Applicant Total
    91
    Review Days
    50

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    Basic Information

    Device Name
    QUALTEX SKIN STAPLE EXTRACTOR
    K Number
    K911204
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4760
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Deroyal Industries, Inc.
    Date Received
    March 19, 1991
    Decision Date
    May 8, 1991
    Product Code
    GDT
    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
    GDT Staple, Removable (Skin)

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