BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇲🇾 Malaysia

    ENDOPLUS

    K Number: K941969 · Decision Jun 22, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    240
    Applicant Total
    61
    Review Days
    61

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    Basic Information

    Device Name
    ENDOPLUS
    K Number
    K941969
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5730
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Wembley Rubber Products (M) Sdn Bhd
    Date Received
    April 22, 1994
    Decision Date
    June 22, 1994
    Product Code
    BTR
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BTR Tube, Tracheal (W/Wo Connector)

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    K953590 COMFIT
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