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

    CARE + PLUS IRREGATION TRAY

    K Number: K863281 · Decision Oct 31, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    237
    Applicant Total
    7
    Review Days
    67

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    Basic Information

    Device Name
    CARE + PLUS IRREGATION TRAY
    K Number
    K863281
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Welmed Systems, Inc.
    Date Received
    August 25, 1986
    Decision Date
    October 31, 1986
    Product Code
    KOD
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KOD Catheter, Urological

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    Other Clearances by Welmed Systems, Inc.

    K Number Device Name
    K863282 CARE + PLUS CATHETER CARE TRAY
    K863497 SUCTION CATHETER KIT
    K863284 I.V. START KIT
    K863283 CARE + PLUS SUTURE REMOVAL TRAY
    K862663 TRACHEOSTOMY CARE TRAY
    K862219 T.P.N. DRESSING CHANGE TRAY