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

    MEDLINE COLLAGEN WOUND DRESSING

    K Number: K060456 · Decision Jun 19, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    134
    Registration Numbers
    134
    Same Product Code
    187
    Applicant Total
    238
    Review Days
    117

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    Basic Information

    Device Name
    MEDLINE COLLAGEN WOUND DRESSING
    K Number
    K060456
    Device Class
    FDA unclassified
    Clearance Type
    Abbreviated
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medline Industries, Inc.
    Date Received
    February 22, 2006
    Decision Date
    June 19, 2006
    Product Code
    KGN
    Advisory Committee
    Unknown
    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
    KGN Wound Dressing With Animal-Derived Material(S)

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