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

    BODY FLUIDS BARRIER KIT

    K Number: K944545 · Decision Nov 2, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    329
    Registration Numbers
    329
    Same Product Code
    598
    Applicant Total
    2
    Review Days
    47

    Basic Information

    Device Name
    BODY FLUIDS BARRIER KIT
    K Number
    K944545
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    ANI SAFETY, INC.
    Date Received
    September 16, 1994
    Decision Date
    November 2, 1994
    Product Code
    FXX
    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
    FXX Mask, Surgical

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    Other Clearances by ANI SAFETY, INC.

    K Number Device Name
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