BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    AMD Ritmed AssureWear VersaGown

    K Number: K190306 · Decision Jan 17, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    67
    Applicant Total
    2
    Review Days
    339

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    Basic Information

    Device Name
    AMD Ritmed AssureWear VersaGown
    K Number
    K190306
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Amd Medicom, Inc.
    Date Received
    February 12, 2019
    Decision Date
    January 17, 2020
    Product Code
    FYC
    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
    FYC Gown, Isolation, Surgical

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    Other Clearances by Amd Medicom, Inc.

    K Number Device Name
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