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

    3.5 & 5.5 OZ. SODIUM CHLORIDE SOLUTION

    K Number: K820460 · Decision Mar 8, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    331
    Registration Numbers
    331
    Same Product Code
    83
    Applicant Total
    15
    Review Days
    17

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    Basic Information

    Device Name
    3.5 & 5.5 OZ. SODIUM CHLORIDE SOLUTION
    K Number
    K820460
    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
    February 19, 1982
    Decision Date
    March 8, 1982
    Product Code
    JOL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    CH
    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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