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

    SNAP-LOCK ADDITIVE CAP #SL 300

    K Number: K854034 · Decision Nov 6, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    86
    Registration Numbers
    86
    Same Product Code
    116
    Applicant Total
    5
    Review Days
    36

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    Basic Information

    Device Name
    SNAP-LOCK ADDITIVE CAP #SL 300
    K Number
    K854034
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5025
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Williams Medical Co.
    Date Received
    October 1, 1985
    Decision Date
    November 6, 1985
    Product Code
    KPE
    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
    KPE Container, I.V.

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    Other Clearances by Williams Medical Co.

    K Number Device Name
    K891159 SODIUM BICARBONATE, U.S.P.
    K854031 SNAP-LOCK ADDITIVE CAP #SL100
    K854033 SNAP-LOCK ADDITIVE CAP #SL400
    K854032 SNAP-LOCK ADDITIVE CAP #SL 200