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

    SILICONE SUMP DRAIN 20 & 40 FRENCH

    K Number: K840324 · Decision Apr 25, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    13
    Applicant Total
    15
    Review Days
    91

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    Basic Information

    Device Name
    SILICONE SUMP DRAIN 20 & 40 FRENCH
    K Number
    K840324
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Superior Plastic Products Corp.
    Date Received
    January 25, 1984
    Decision Date
    April 25, 1984
    Product Code
    JCY
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JCY Catheter, Infusion

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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
    K841945 ENTERAL FEEDING BOTTLE
    K841630 ENTERAL NUTRITION PUMP
    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.
    Search all 15 clearances from Superior Plastic Products Corp. →