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

    SHAW SUN SYSTEMS MODEL 1600

    K Number: K882331 · Decision Jun 22, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    80
    Applicant Total
    3
    Review Days
    16

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    Basic Information

    Device Name
    SHAW SUN SYSTEMS MODEL 1600
    K Number
    K882331
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4635
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Shaw Sun Systems
    Date Received
    June 6, 1988
    Decision Date
    June 22, 1988
    Product Code
    LEJ
    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
    LEJ Booth, Sun Tan

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    Other Clearances by Shaw Sun Systems

    K Number Device Name
    K885184 SHAW SUN SYSTEMS MODEL 2400
    K854515 SHAW SUN SYSTEMS 1000, 2000 & 3200