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

    PROVIDER CAP SET

    K Number: K841028 · Decision Apr 5, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    10
    Review Days
    24

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    Basic Information

    Device Name
    PROVIDER CAP SET
    K Number
    K841028
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Pancretec, Inc.
    Date Received
    March 12, 1984
    Decision Date
    April 5, 1984
    Product Code
    FPA
    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
    FPA Set, Administration, Intravascular

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    K843463 PROVIDER BAG SPIKE W/12 MICROBORE EXTEN
    K841373 PROVIDER IV MODEL 2000 INFUSIN SYS
    K841017 PROVIDER INFUSION SET
    K841027 PROVIDER SITE PREP & CHECK STRIP KIT
    K833983 PROVIDER U-100 INSULIN INFUSION SYS
    K841018 PANCRETEC PUMP CHECK