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

    MEDIFLEX INJECTION CAP

    K Number: K855039 · Decision Jan 24, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    3
    Applicant Total
    9
    Review Days
    38

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    Basic Information

    Device Name
    MEDIFLEX INJECTION CAP
    K Number
    K855039
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Mediflex Intl.
    Date Received
    December 17, 1985
    Decision Date
    January 24, 1986
    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 Mediflex Intl.

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    K884243 BLOOD TUBING SET
    K863496 MEDIFLEX TRANSDUCER PROTECTOR
    K854346 MEDIFLEX DISPOSABLE TUBING CLAMP
    K852106 I.V. ADMINISTRATION SET
    K843126 MEDIFLEX DRAINAGE BAG