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

    ENTERAL FEEDING BOTTLE

    K Number: K841945 · Decision Jul 26, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    15
    Review Days
    76

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    Basic Information

    Device Name
    ENTERAL FEEDING BOTTLE
    K Number
    K841945
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Superior Plastic Products Corp.
    Date Received
    May 11, 1984
    Decision Date
    July 26, 1984
    Product Code
    KNT
    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
    KNT Tubes, Gastrointestinal (And Accessories)

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    Other Clearances by Superior Plastic Products Corp.

    K Number Device Name
    K851981 NO. 5300-3 1/2 FRENCH UMBILICAL VESSEL CATH. ETC.
    K843975 9 FRENCH 42LONG POLYURETHANE GRADUATED ENTERIC FE
    K841630 ENTERAL NUTRITION PUMP
    K840324 SILICONE SUMP DRAIN 20 & 40 FRENCH
    K840323 SILICONE SUCTION & IRRIGATION DRAIN
    K841480 INFECTION CONTROL VALVE
    K833687 DISPOS. ENTERIC FEEDING TUBES W/SAFE-T
    K833947 SUPERIOR ENTERNAL FEEDING SYSTEM
    K820460 3.5 & 5.5 OZ. SODIUM CHLORIDE SOLUTION
    K812312 STERILE WATER 4OZ.
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