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

    BARRIER N95 PARTICULATE RESPIRATOR

    K Number: K102923 · Decision Nov 19, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    224
    Registration Numbers
    224
    Same Product Code
    34
    Applicant Total
    9
    Review Days
    49

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    Basic Information

    Device Name
    BARRIER N95 PARTICULATE RESPIRATOR
    K Number
    K102923
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Molnlycke Health Care
    Date Received
    October 1, 2010
    Decision Date
    November 19, 2010
    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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    Other Clearances by Molnlycke Health Care

    K Number Device Name
    K130852 AVANCE® FOAM ABDOMINAL DRESSING KIT
    K130040 MEPITEL AG
    K123892 MEPILEX TRANSFER AG
    K122132 AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE) AVANCE TRANSPARENT FILM AVANCE FOAM
    K100029 MEPILEX BORDER AG DRESSING
    K061554 MEPILEX AG ABSORBENT SILICONE-COATED DRESSING
    K050786 BARRIER SURGICAL GOWNS
    K031131 KLINIDRAPE SURGICAL DRAPES