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

    AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES

    K Number: K972646 · Decision Aug 21, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    292
    Registration Numbers
    292
    Same Product Code
    28
    Applicant Total
    5
    Review Days
    37

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    Basic Information

    Device Name
    AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES
    K Number
    K972646
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4022
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ludlow Technical Products
    Date Received
    July 15, 1997
    Decision Date
    August 21, 1997
    Product Code
    NAE
    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
    NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic

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