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510(k) Data Aggregation

    K Number
    K972719
    Device Name
    CLARICEL STERILIZATION POUCHES AND STERILIZATION REELS
    Manufacturer
    MEDICEL, S.A. DE C.V.
    Date Cleared
    1999-02-04

    (563 days)

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

    MEDICEL, S.A. DE C.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Claricel sterilization pouches and reels are indicated to enclose another medical device that is to be steam or ethylene oxide sterilized by a health care provider, following the ANSI/AAMI ST-46 or ST-41 sterilization recommendations.
    Device Description
    Claricel Sterilization Pouches and Reels
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