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

    STERILE WATER 4OZ.

    K Number: K812312 · Decision Nov 13, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    331
    Registration Numbers
    331
    Same Product Code
    83
    Applicant Total
    15
    Review Days
    88

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    Basic Information

    Device Name
    STERILE WATER 4OZ.
    K Number
    K812312
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6740
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Superior Plastic Products Corp.
    Date Received
    August 17, 1981
    Decision Date
    November 13, 1981
    Product Code
    JOL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JOL Catheter And Tip, Suction

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    HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE

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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
    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
    Search all 15 clearances from Superior Plastic Products Corp. →