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510(k) Data Aggregation

    K Number
    K031022
    Device Name
    PROTEC-TOP, STERIDENT, BENTO
    Manufacturer
    RONPAK, INC.
    Date Cleared
    2003-04-14

    (14 days)

    Product Code
    FRG
    Regulation Number
    880.6850
    Why did this record match?
    Applicant Name (Manufacturer) :

    RONPAK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Ronclave® packaging is indicated for use by health care facilities for the packaging, sterilization (by steam, chemical vapor or dry heat) and maintenance of sterility during storage of various medical items. The chemical indicator imprint is intended to allow the user to distinguish packages that have been processed from those that have not by changing its color from green to blue-gray.
    Device Description
    Not Found
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