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

    ADVANCED CARE HYDROPHILIC WOUND DRESSINGS

    K Number: K961662 · Decision Jun 13, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    221
    Applicant Total
    1
    Review Days
    44

    Basic Information

    Device Name
    ADVANCED CARE HYDROPHILIC WOUND DRESSINGS
    K Number
    K961662
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5090
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MARINER BIOMEDICAL, INC.
    Date Received
    April 30, 1996
    Decision Date
    June 13, 1996
    Product Code
    KMF
    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
    KMF Bandage, Liquid

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