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

    BARRIER LASER PLUS FACE MASK

    K Number: K934194 · Decision Mar 28, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    329
    Registration Numbers
    329
    Same Product Code
    598
    Applicant Total
    53
    Review Days
    214

    Basic Information

    Device Name
    BARRIER LASER PLUS FACE MASK
    K Number
    K934194
    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
    JOHNSON & JOHNSON MEDICAL, INC.
    Date Received
    August 26, 1993
    Decision Date
    March 28, 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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