BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    NU-THOR THORACOSTOMY KIT

    K Number: K842666 · Decision Sep 20, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    214
    Registration Numbers
    214
    Same Product Code
    28
    Applicant Total
    12
    Review Days
    72

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    Basic Information

    Device Name
    NU-THOR THORACOSTOMY KIT
    K Number
    K842666
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Intl. Medical Devices , Ltd.
    Date Received
    July 10, 1984
    Decision Date
    September 20, 1984
    Product Code
    KGZ
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KGZ Accessories, Catheter

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    K862909 RE-TRAKE WEISS EMERGENCY AIRWAY & THORACIC SYSTEM
    K850398 NU-CATH EMERGENCY KIT
    K843785 WISSS PEDIATRIC TRACH- TUBE W/OBTURATOR
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