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

    VACUTAINER BRAND NEEDLE DISPOSAL CONTAINER

    K Number: K943138 · Decision Nov 28, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    112
    Applicant Total
    8
    Review Days
    152

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    Basic Information

    Device Name
    VACUTAINER BRAND NEEDLE DISPOSAL CONTAINER
    K Number
    K943138
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Med-Safe Systems, Inc.
    Date Received
    June 29, 1994
    Decision Date
    November 28, 1994
    Product Code
    MMK
    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
    MMK Container, Sharps

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    Other Clearances by Med-Safe Systems, Inc.

    K Number Device Name
    K943139 B-D GUARDIAN ONE PIECE SHARPS COLLECTORS
    K943137 B-D/BFI MAIL DISPOSAL SERVICE
    K943141 B-D GUARDIAN POINT OF USE HORIZONTAL AND SIDE ENTRY SHARPS COLLECTORS
    K943134 B-D GUARDIAN NESTABLE SHARPS COLLECTORS
    K943135 MED-SAFE INSULIN SHARPS CONTAINER
    K943136 B-D GUARDIAN POINT-OF-USE VERTICAL ENTRY SHARPS COLLECTORS
    K943140 B-D GURADIAN CHEMOTHERAPY SHARPS COLLECTORS