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

    MICROWAVAE DELIVERY SYSTEM #MW2000

    K Number: K010589 · Decision Mar 19, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    20

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    Basic Information

    Device Name
    MICROWAVAE DELIVERY SYSTEM #MW2000
    K Number
    K010589
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Mw Medical, Inc.
    Date Received
    February 27, 2001
    Decision Date
    March 19, 2001
    Product Code
    MWY
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MWY System, Microwave, Hair Removal

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MWY), ordered by most recent decision date.

    MICROWAVE DELIVERY SYSTEM, MODEL MMC-300

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