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

    HIGH VAC

    K Number: K920492 · Decision May 11, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    147
    Registration Numbers
    147
    Same Product Code
    17
    Applicant Total
    1
    Review Days
    98

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    Basic Information

    Device Name
    HIGH VAC
    K Number
    K920492
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hygoplastic, Inc.
    Date Received
    February 3, 1992
    Decision Date
    May 11, 1992
    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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