BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER

    K Number: K103277 · Decision Apr 19, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    205
    Applicant Total
    2
    Review Days
    165

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    Basic Information

    Device Name
    3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER
    K Number
    K103277
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2800
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    3M Company-3M Health Care
    Date Received
    November 5, 2010
    Decision Date
    April 19, 2011
    Product Code
    FRC
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FRC Indicator, Biological Sterilization Process

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    Other Clearances by 3M Company-3M Health Care

    K Number Device Name
    K080620 MODIFICATION TO 3M TEGADERM CHG DRESSING