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510(k) Data Aggregation

    K Number
    K050131
    Device Name
    INSOSAFE BAK'SNAP RETRACTABLE INSULIN SAFETY SYRINGE
    Manufacturer
    M.K. MEDITECH CO. LTD.
    Date Cleared
    2005-04-05

    (74 days)

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

    M.K. MEDITECH CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InsoSAFE™ Bak'SNAP™ Retractable Insulin Safety Syringe is a sterile, single-use, disposable and non-reusable, manual, retractable safety syringe intended for subcutaneous injection of insulin into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.
    Device Description
    The InsoSAFE™ Bak'SNAP™ Retractable Insulin Safety Syringe is a sterile, singleuse, disposable and non-reusable, manual, retractable safety syringe intended for injection of insulin into the body, while reducing the risk of sharps injuries and the potential for syringe reuse. It is a sterile, single-use, with a pre-attached single lumen hypodermic needle. Syringe volumes include 1 mL, 0.5 mL, and 0.3 mL. Needles range in size from 25G to 29G, with lengths of 3/8 inch to 1/2 inches. The InsoSAFE™ is provided individually wrapped, in shelf boxes of 100 units.
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    K Number
    K034031
    Device Name
    10 ML BAK'SNAP DUOPROSS RETRACTABLE SAFETY SYRINGE
    Manufacturer
    M.K. MEDITECH CO. LTD.
    Date Cleared
    2004-01-21

    (23 days)

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

    M.K. MEDITECH CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bak'Snap DuoProSS™ Retractable Safety Syringe is a sterile, single-use, disposable and non-reusable, manual, retractable safety syringe intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringc reuse.
    Device Description
    The 10 mL Bak'Snap DuoProSS™ Retractable Safety Syringe is a sterile, single-use, disposable and non-rcusable, manual, retractable safety syringe provided with or without needle. The modifications to the cleared product are the addition of a brand name, a change in syringe volume, and a change in a single syringe material.
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    K Number
    K031594
    Device Name
    BAK'SNAP DUOPRO SAFETY SYRING (DUOPROSS) SAFETY'TRAY ALLERGY SAFETY SYRINGE TRAY
    Manufacturer
    M.K. MEDITECH CO. LTD.
    Date Cleared
    2003-06-06

    (16 days)

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

    M.K. MEDITECH CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 1 mL Bak'Snap DuoPro™ Safety Syringe (DuoProSS™) is a sterile, singleuse, disposable and non-reusable, manual, retractable safety syringe intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.
    Device Description
    The 1 mL Bak'Snap DuoPro™ Safety Syringe (DuoProSSTM) is a sterile, singleuse, disposable and non-reusable, manual, retractable safety syringe provided with permanently attached needle. The Safety Tray Safety Allergy Syringe Tray consists of 25 Bak'Snap syringes within a single sterile barrier.
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    K Number
    K022806
    Device Name
    DUOPRO SAFETY SYRINGE (DUOPROSS)
    Manufacturer
    M.K. MEDITECH CO. LTD.
    Date Cleared
    2002-09-19

    (27 days)

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

    M.K. MEDITECH CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DuoPro™ Safety Syringe (DuoProSS™) is a sterile, single-use, disposable and nonreusable, manual retractable safety syringe intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.
    Device Description
    The modified DuoPro™ Safety Syringe (DuoProSS™) is a sterile, single-use, disposable and non-reusable, manual, 3 mL or 5 mL retractable safety syringe, provided with or without needle in various product configurations.
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    K Number
    K020623
    Device Name
    DUOPRO SAFETY SYRINGE (DUOPROSS)
    Manufacturer
    M.K. MEDITECH CO. LTD.
    Date Cleared
    2002-05-02

    (65 days)

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

    M.K. MEDITECH CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DuoPro Safety Syringe (DuoProSS™) is a sterile, single-use, disposable and non-reusable, manual, retractable safety syringe which is intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.
    Device Description
    The DuoPro Safety Syringe (DuoProSS™) is a sterile, single-use, disposable and non-reusable, manual, retractable 3 mL safety syringe, provided with or without needle in various product configurations.
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