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

    TAP EXPRESS EJECTOR

    K Number: K941164 · Decision May 18, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    16
    Applicant Total
    1
    Review Days
    68

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    Basic Information

    Device Name
    TAP EXPRESS EJECTOR
    K Number
    K941164
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Tap Express, Inc.
    Date Received
    March 11, 1994
    Decision Date
    May 18, 1994
    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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