BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    Mercy babyTAPE

    K Number: K191174 · Decision Oct 10, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    162

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    Basic Information

    Device Name
    Mercy babyTAPE
    K Number
    K191174
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Children'S Mercy Hospital
    Date Received
    May 1, 2019
    Decision Date
    October 10, 2019
    Product Code
    PIR
    Advisory Committee
    General, Plastic Surgery
    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
    PIR Mercy Tape 2d And 3d Models

    Similar 510(k) Clearances

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

    2D Mercy TAPE & 3D Mercy TAPE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery
    View all

    Other Clearances by Children'S Mercy Hospital

    K Number Device Name
    K142469 2D Mercy TAPE & 3D Mercy TAPE