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

    3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S

    K Number: K171116 · Decision Aug 10, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    224
    Registration Numbers
    224
    Same Product Code
    34
    Applicant Total
    21
    Review Days
    118

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    Basic Information

    Device Name
    3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S
    K Number
    K171116
    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
    3M Healthcare
    Date Received
    April 14, 2017
    Decision Date
    August 10, 2017
    Product Code
    MSH
    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
    MSH Respirator, Surgical

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