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

    TT101, MODELS TT 101-1,-2,-3,-4,-5,-6,-7,-8

    K Number: K061060 · Decision Jul 3, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    2
    Review Days
    77

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    Basic Information

    Device Name
    TT101, MODELS TT 101-1,-2,-3,-4,-5,-6,-7,-8
    K Number
    K061060
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tissue Technologies Holdings, LLC
    Date Received
    April 17, 2006
    Decision Date
    July 3, 2006
    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 Tissue Technologies Holdings, LLC

    K Number Device Name
    K081246 TT-102