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

    ULTIMED ULTICARE SAFETY SYRINGE

    K Number: K080600 · Decision Jun 25, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    161
    Applicant Total
    8
    Review Days
    114

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    Basic Information

    Device Name
    ULTIMED ULTICARE SAFETY SYRINGE
    K Number
    K080600
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ultimed, Inc.
    Date Received
    March 3, 2008
    Decision Date
    June 25, 2008
    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 Ultimed, Inc.

    K Number Device Name
    K100812 ULTICARE DISPOSABLE PEN NEEDLES
    K081449 ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER
    K062702 ULTICARE DISPOSABLE SYRINGES AND NEEDLES
    K050464 ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 GAUGE X 1/2
    K033794 ULTICARE DISPOSABLE SYRINGE 3 ML/CC
    K021983 ULTI GUARD HOME INSULIN SYRINGE CONTAINER
    K994230 ULTICARE DISPOSABLE SYRINGE