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

    10 ML BAK'SNAP DUOPROSS RETRACTABLE SAFETY SYRINGE

    K Number: K034031 · Decision Jan 21, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    161
    Applicant Total
    5
    Review Days
    23

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    Basic Information

    Device Name
    10 ML BAK'SNAP DUOPROSS RETRACTABLE SAFETY SYRINGE
    K Number
    K034031
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    M.K. Meditech Co. , Ltd.
    Date Received
    December 29, 2003
    Decision Date
    January 21, 2004
    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
    K031594 BAK'SNAP DUOPRO SAFETY SYRING (DUOPROSS) SAFETY'TRAY ALLERGY SAFETY SYRINGE TRAY
    K022806 DUOPRO SAFETY SYRINGE (DUOPROSS)
    K020623 DUOPRO SAFETY SYRINGE (DUOPROSS)