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

    ULTICARE SAFETY INSULIN SYRINGE

    K Number: K103011 · Decision Feb 2, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    161
    Applicant Total
    21
    Review Days
    113

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    Basic Information

    Device Name
    ULTICARE SAFETY INSULIN SYRINGE
    K Number
    K103011
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ulti-Med Intl., Inc.
    Date Received
    October 12, 2010
    Decision Date
    February 2, 2011
    Product Code
    MEG
    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
    MEG Syringe, Antistick

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