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

    PARALLEL-A-PREP

    K Number: K801853 · Decision Aug 13, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    9

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    Basic Information

    Device Name
    PARALLEL-A-PREP
    K Number
    K801853
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    C.D. Charles, Inc.
    Date Received
    August 4, 1980
    Decision Date
    August 13, 1980
    Product Code
    EGI
    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
    EGI Parallelometer