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510(k) Data Aggregation

    K Number
    K160668
    Device Name
    HumaPen Savvio
    Manufacturer
    Eli Lilly and Company, Inc.
    Date Cleared
    2016-06-03

    (86 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Eli Lilly and Company, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HumaPen Savvio is a reusable insulin pen intended for the self-injection of HUMALOG® (U-100, insulin lispro for injection) available in 3 mL cartridges using disposable pen needles (sold separately).
    Device Description
    The HumaPen Savvio is a reusable mechanical pen-injector designed for use for the self-injection of insulin. The pen-injector is intended for use with Eli Lilly and Company 3 mL insulin cartridges and single-use, detachable, and disposable pen needles (supplied separately). The pen-injector allows the user to dial the desired dose from 1 to 60 units, one unit at a time.
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    K Number
    K151686
    Device Name
    HumanPen Ergo II
    Manufacturer
    ELI LILLY AND COMPANY, INC.
    Date Cleared
    2015-12-30

    (190 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELI LILLY AND COMPANY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HumaPen Ergo II is a reusable insulin Pen intended for the self-injection of HUMALOG® (U-100, insulin lispro for injection) available in 3 mL Cartridges using disposable Pen Needles (sold separately).
    Device Description
    The HumaPen Ergo II is a reusable mechanical pen-injector designed for use for the self-injection of insulin. The pen-injector is intended for use with Eli Lilly and Company 3 mL insulin cartridges and single-use, detachable, and disposable pen needles (supplied separately). The pen-injector allows the user to dial the desired dose from 1 to 60 units, one unit at a time.
    Ask a Question

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