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

    SAFETY INJECTION SYSTEM

    K Number: K962999 · Decision Jan 22, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    44
    Applicant Total
    1
    Review Days
    173

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    Basic Information

    Device Name
    SAFETY INJECTION SYSTEM
    K Number
    K962999
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.6770
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Integritech, Inc.
    Date Received
    August 2, 1996
    Decision Date
    January 22, 1997
    Product Code
    EJI
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EJI Syringe, Cartridge

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