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

    MERIT HI-FLEX(TM)

    K Number: K883718 · Decision Jan 30, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    63
    Applicant Total
    178
    Review Days
    152

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    Basic Information

    Device Name
    MERIT HI-FLEX(TM)
    K Number
    K883718
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Merit Medical Systems, Inc.
    Date Received
    August 31, 1988
    Decision Date
    January 30, 1989
    Product Code
    FPK
    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
    FPK Tubing, Fluid Delivery

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