BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SURGICAL ASPIRATOR TIPS

    K Number: K781592 · Decision Dec 4, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    147
    Registration Numbers
    147
    Same Product Code
    17
    Applicant Total
    8
    Review Days
    77

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    Basic Information

    Device Name
    SURGICAL ASPIRATOR TIPS
    K Number
    K781592
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Henry Schein, Inc.
    Date Received
    September 18, 1978
    Decision Date
    December 4, 1978
    Product Code
    DYN
    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
    DYN Mouthpiece, Saliva Ejector

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