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

    SILICONE ELASTOMER INFUSION CATHETER

    K Number: K813606 · Decision Jan 18, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    13
    Applicant Total
    39
    Review Days
    20

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    Basic Information

    Device Name
    SILICONE ELASTOMER INFUSION CATHETER
    K Number
    K813606
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Quest Medical, Inc.
    Date Received
    December 29, 1981
    Decision Date
    January 18, 1982
    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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