BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    RESUBMITTED 1,3 & 4 WAY STOPCOCKS, VARIOUS PARTS

    K Number: K884435 · Decision Nov 8, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    88
    Applicant Total
    10
    Review Days
    26

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    Basic Information

    Device Name
    RESUBMITTED 1,3 & 4 WAY STOPCOCKS, VARIOUS PARTS
    K Number
    K884435
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Clinical Connections, Inc.
    Date Received
    October 13, 1988
    Decision Date
    November 8, 1988
    Product Code
    FMG
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FMG Stopcock, I.V. Set

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    Other Clearances by Clinical Connections, Inc.

    K Number Device Name
    K871540 SWIVEL CONNECTORS #014452/#014453/#014459-120
    K870325 #014160-TAB TUBING ROTATOR ADAPTOR
    K870477 DEVICE CONNECTORS #000299-000 3/8 X 3/8 X 3/8 Y
    K870913 INJECTION SITE #014456-120
    K870912 T-CONNECTORS 014500/014501/014502/014503-120
    K870324 #014460-120 3-WAY & #014461-120 4-WAY STOPCOCK
    K870394 HYDROPHOBIC #6194418/HYDRAPHILIC #6104418 FILTERS
    K870073 MANIFOLD SWIVEL ROTATOR MODELS 014320 & 014321-TAB
    K870326 VARIOUS LUER AND TUBING FITTINGS