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

    CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTION

    K Number: K924755 · Decision Jun 22, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    6
    Applicant Total
    81
    Review Days
    272

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    Basic Information

    Device Name
    CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTION
    K Number
    K924755
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Convatec, A Division of E.R. Squibb & Sons
    Date Received
    September 23, 1992
    Decision Date
    June 22, 1993
    Product Code
    EXI
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EXI Device, Paste-On For Incontinence, Sterile

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