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

    MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385

    K Number: K010377 · Decision Apr 5, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    46
    Applicant Total
    9
    Review Days
    56

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    Basic Information

    Device Name
    MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385
    K Number
    K010377
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6920
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Minimed, Inc.
    Date Received
    February 8, 2001
    Decision Date
    April 5, 2001
    Product Code
    KZH
    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
    KZH Introducer, Syringe Needle

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