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

    RE-BAG MULTI-USE POUCH, LARGE & SMALL

    K Number: K954185 · Decision Dec 4, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    279
    Applicant Total
    23
    Review Days
    89

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    Basic Information

    Device Name
    RE-BAG MULTI-USE POUCH, LARGE & SMALL
    K Number
    K954185
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Miltex, Inc.
    Date Received
    September 6, 1995
    Decision Date
    December 4, 1995
    Product Code
    KCT
    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
    KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

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    K072563 MILTEX RIGID CONTAINER SYSTEMS
    K061033 MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS)
    K052018 MILTEX LIGATING CLIP
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    K013888 FIXATION (STEINMANN) PINS
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