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

    PEDIATRIC DRAIN BAG

    K Number: K896581 · Decision Jan 31, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    75

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    Basic Information

    Device Name
    PEDIATRIC DRAIN BAG
    K Number
    K896581
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Laytech Medical Co.
    Date Received
    November 17, 1989
    Decision Date
    January 31, 1990
    Product Code
    FFH
    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
    FFH Collector, Urine, Pediatric, For Indwelling Catheter

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FFH), ordered by most recent decision date.

    PEDIATRIC AND INFANT CATH KITS

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    FDA Class 2 ·Gastroenterology, Urology

    INTECARE PEDIATRIC URINE COLLECTOR

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
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    Other Clearances by Laytech Medical Co.

    K Number Device Name
    K893827 PEAK FLOW RATE METER