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

    HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)

    K Number: K181959 · Decision Mar 22, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    321
    Applicant Total
    2
    Review Days
    242

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    Basic Information

    Device Name
    HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)
    K Number
    K181959
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Owens & Minor Halyard, Inc.
    Date Received
    July 23, 2018
    Decision Date
    March 22, 2019
    Product Code
    FRG
    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
    FRG Wrap, Sterilization

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