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

    HERMAL WOUND CARE KIT

    K Number: K895817 · Decision Jan 19, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    502
    Registration Numbers
    502
    Same Product Code
    106
    Applicant Total
    6
    Review Days
    112

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    Basic Information

    Device Name
    HERMAL WOUND CARE KIT
    K Number
    K895817
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4020
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Stiefel Research Institute, Inc.
    Date Received
    September 29, 1989
    Decision Date
    January 19, 1990
    Product Code
    NAD
    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
    NAD Dressing, Wound, Occlusive

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    K896724 CRYOJET LIQUID NITROGEN SPRAY CRYOSURGICAL INSTRU.
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