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510(k) Data Aggregation

    K Number
    K051667
    Device Name
    EZ-JECT
    Manufacturer
    INDOLOR, LTD.
    Date Cleared
    2005-09-27

    (97 days)

    Product Code
    KZH
    Regulation Number
    880.6920
    Why did this record match?
    Applicant Name (Manufacturer) :

    INDOLOR, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Modified Easy-Ject Automatic Injector Device (also known as EZ-Ject) is an automatic injection device with a cooling mechanism for injection and needle withdrawal.
    Device Description
    The Modified Easy-Ject Automatic Injector is a hand held device that performs automates a disk shaped cooling element that cools the skin prior to the needle injection. The Modified Easy-Ject Automatic Injector Device is an automatic injection device with a cooling mechanism for injection and needle withdrawal.
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