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

    COPAXONE (GLATIRAMER ACETATE FOR INJECTION) EZ-JECT FROM SHARED SOLUTIONS

    K Number: K974171 · Decision Dec 19, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    46
    Applicant Total
    2
    Review Days
    44

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    Basic Information

    Device Name
    COPAXONE (GLATIRAMER ACETATE FOR INJECTION) EZ-JECT FROM SHARED SOLUTIONS
    K Number
    K974171
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6920
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Teva Medical, Ltd.
    Date Received
    November 5, 1997
    Decision Date
    December 19, 1997
    Product Code
    KZH
    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
    KZH Introducer, Syringe Needle

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