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510(k) Data Aggregation

    K Number
    K062780
    Device Name
    CLICKZIP, MODEL U-100 INSULIN SAFETY SYRINGE
    Manufacturer
    MEDICAL DEVICE MANUFACTURER (THAILAND) LTD.
    Date Cleared
    2007-01-05

    (109 days)

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

    MEDICAL DEVICE MANUFACTURER (THAILAND) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ClickZip™ Needle Retractable Safety Syringe Insulin 1 ml. with U-100 strength insulin is to be used for subcutaneous injection of insulin into a patient and is intended to prevent needle stick injuries. In addition, when the syringe user breaks the plunger, re-use of the syringe is prevented.
    Device Description
    The ClickZip™ Needle Retractable Safety Syringe Insulin 1 ml. is sterile, single-use, disposable and non-reusable, needle retractable safety syringe, provided with various size of needle.
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    K Number
    K051694
    Device Name
    CLICKZIP NEEDLE RETRACTABLE SAFETY SYRINGE
    Manufacturer
    MEDICAL DEVICE MANUFACTURER (THAILAND) LTD.
    Date Cleared
    2005-12-21

    (181 days)

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

    MEDICAL DEVICE MANUFACTURER (THAILAND) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ClickZip™ Needle Retractable Safety Syringe is to be used for intra-muscular of The ChekZip - Needle Ketractaons into a patient and is intended to prevent needle stick subcutaneous injection of medications into a patient and is intended on the subcutaneous injection of medications into a partificant (1) Needle Retractable injuries. It is currently available in Imal for withdrewing blood In addition when the injuries. It is currently available in this only and simbleding blood. In addition, when the Safely Syringe 13 not intenably the syringe is prevented.
    Device Description
    The ClickZip™ Needle Retractable Safety Syringe is sterile, single-use, disposable and nonreusable, needle retractable safety syringe, provided with various size of needle. The products are supplied in many sizes i.e. 1, 3 and 5 ml.
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