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

    MODIFICATION TO 3M TEGADERM CHG DRESSING

    K Number: K080620 · Decision May 19, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    2
    Review Days
    76

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    Basic Information

    Device Name
    MODIFICATION TO 3M TEGADERM CHG DRESSING
    K Number
    K080620
    Device Class
    FDA unclassified
    Clearance Type
    Special
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    3M Company-3M Health Care
    Date Received
    March 4, 2008
    Decision Date
    May 19, 2008
    Product Code
    FRO
    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
    FRO Dressing, Wound, Drug

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    Other Clearances by 3M Company-3M Health Care

    K Number Device Name
    K103277 3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER