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

    KLEIN CONNECTOR(TM)

    K Number: K901716 · Decision May 11, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    3
    Applicant Total
    5
    Review Days
    28

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    Basic Information

    Device Name
    KLEIN CONNECTOR(TM)
    K Number
    K901716
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Jeff Klein Surgical, Inc.
    Date Received
    April 13, 1990
    Decision Date
    May 11, 1990
    Product Code
    GCE
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GCE Adaptor, Catheter

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    Other Clearances by Jeff Klein Surgical, Inc.

    K Number Device Name
    K901718 KLEIN LAMPREY-CANNULA(TM)
    K901717 KLEIN MICRO-CANNULA(TM)
    K901719 KLEIN MICRO-CANNULA HANDLE(TM)
    K901715 KLEIN CORK(TM)