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

    URINARY DRAINAGE BAG CADDY

    K Number: K931727 · Decision Jul 23, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    119
    Registration Numbers
    119
    Same Product Code
    17
    Applicant Total
    6
    Review Days
    142

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    Basic Information

    Device Name
    URINARY DRAINAGE BAG CADDY
    K Number
    K931727
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Neotech Products, Inc.
    Date Received
    March 3, 1993
    Decision Date
    July 23, 1993
    Product Code
    FAQ
    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
    FAQ Bag, Urine Collection, Leg, For External Use, Sterile

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    Other Clearances by Neotech Products, Inc.

    K Number Device Name
    K011564 NEOLEAD
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    K890425 NEOTECH MUCUS TRAP W/CATHETER
    K882203 NEOTECH UNIVERSAL ADAPTER
    K880487 NEOTECH MECONIUM ASPIRATOR (STERILE)