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

    SAFE TIP SYRINGE

    K Number: K060668 · Decision Jun 12, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    161
    Applicant Total
    2
    Review Days
    90

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    Basic Information

    Device Name
    SAFE TIP SYRINGE
    K Number
    K060668
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Devon Safety Products, Inc.
    Date Received
    March 14, 2006
    Decision Date
    June 12, 2006
    Product Code
    MEG
    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
    MEG Syringe, Antistick

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    Other Clearances by Devon Safety Products, Inc.

    K Number Device Name
    K052551 DEVON STANDARD SYRINGE, HYPODERMIC NEEDLE AND INSULIN SYRINGE