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

    MONARCH STERILIZATION CONTAINER SYSTEM

    K Number: K850289 · Decision Aug 15, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    203
    Registration Numbers
    203
    Same Product Code
    316
    Applicant Total
    2
    Review Days
    203

    Basic Information

    Device Name
    MONARCH STERILIZATION CONTAINER SYSTEM
    K Number
    K850289
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    MONARCH PRODUCTS, INC.
    Date Received
    January 24, 1985
    Decision Date
    August 15, 1985
    Product Code
    FRG
    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
    FRG Wrap, Sterilization

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    Other Clearances by MONARCH PRODUCTS, INC.

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    K911760 MONARCH STERILIZATION CONTAINER SYST, MODIFICATION