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

    VELOPEX AQUACUT FLUID ABRASION UNIT

    K Number: K024105 · Decision Oct 9, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    47
    Applicant Total
    3
    Review Days
    300

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    Basic Information

    Device Name
    VELOPEX AQUACUT FLUID ABRASION UNIT
    K Number
    K024105
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.6080
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Velopex International, Inc.
    Date Received
    December 13, 2002
    Decision Date
    October 9, 2003
    Product Code
    KOJ
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KOJ Airbrush

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