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

    TRACHEOSTOMY CARE KIT

    K Number: K761190 · Decision Dec 16, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    127
    Applicant Total
    15
    Review Days
    10

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    Basic Information

    Device Name
    TRACHEOSTOMY CARE KIT
    K Number
    K761190
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Superior Plastic Products Corp.
    Date Received
    December 6, 1976
    Decision Date
    December 16, 1976
    Product Code
    BTO
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BTO Tube, Tracheostomy (W/Wo Connector)

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    5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mm

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    PRIMED TRACHEOSTOMY TUBES (MULTIPLE)

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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.
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    K841945 ENTERAL FEEDING BOTTLE
    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
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