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

    AIRPREP SYSTEM - MODEL 9001

    K Number: K974488 · Decision May 26, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    47
    Applicant Total
    5
    Review Days
    181

    Basic Information

    Device Name
    AIRPREP SYSTEM - MODEL 9001
    K Number
    K974488
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.6080
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    ASI MEDICAL, INC.
    Date Received
    November 26, 1997
    Decision Date
    May 26, 1998
    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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