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

    BAK'SNAP DUOPRO SAFETY SYRING (DUOPROSS) SAFETY'TRAY ALLERGY SAFETY SYRINGE TRAY

    K Number: K031594 · Decision Jun 6, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    161
    Applicant Total
    5
    Review Days
    16

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    Basic Information

    Device Name
    BAK'SNAP DUOPRO SAFETY SYRING (DUOPROSS) SAFETY'TRAY ALLERGY SAFETY SYRINGE TRAY
    K Number
    K031594
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    M.K. Meditech Co. , Ltd.
    Date Received
    May 21, 2003
    Decision Date
    June 6, 2003
    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 M.K. Meditech Co. , Ltd.

    K Number Device Name
    K050131 INSOSAFE BAK'SNAP RETRACTABLE INSULIN SAFETY SYRINGE
    K034031 10 ML BAK'SNAP DUOPROSS RETRACTABLE SAFETY SYRINGE
    K022806 DUOPRO SAFETY SYRINGE (DUOPROSS)
    K020623 DUOPRO SAFETY SYRINGE (DUOPROSS)