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

    DESCRIBE PFD Patch

    K Number: K172689 · Decision Nov 29, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    84

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    Basic Information

    Device Name
    DESCRIBE PFD Patch
    K Number
    K172689
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Merz North America, Inc.
    Date Received
    September 6, 2017
    Decision Date
    November 29, 2017
    Product Code
    PKO
    Advisory Committee
    General, Plastic Surgery
    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
    PKO Transparent Patch For Use In Treatment Of Tattoos

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (PKO), ordered by most recent decision date.

    DeScribe Transparent PFD Patch

    FDA 510(k)
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