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

    PRESTIGE AMERITECH FACE MASK

    K Number: K061716 · Decision Aug 14, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    606
    Applicant Total
    5
    Review Days
    56

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    Basic Information

    Device Name
    PRESTIGE AMERITECH FACE MASK
    K Number
    K061716
    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
    Prestige Ameritech
    Date Received
    June 19, 2006
    Decision Date
    August 14, 2006
    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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    K102092 PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES