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

    DENTAL OFFICE ENVIRONMENT CONTROL UNIT

    K Number: K780701 · Decision May 16, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    16
    Applicant Total
    1
    Review Days
    20

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    Basic Information

    Device Name
    DENTAL OFFICE ENVIRONMENT CONTROL UNIT
    K Number
    K780701
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Laminaire Corp.
    Date Received
    April 26, 1978
    Decision Date
    May 16, 1978
    Product Code
    EHZ
    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
    EHZ Evacuator, Oral Cavity

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