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510(k) Data Aggregation

    K Number
    K974180
    Device Name
    STERI-TAMP
    Manufacturer
    PHARMACY, INC.
    Date Cleared
    1998-02-24

    (110 days)

    Product Code
    KPE
    Regulation Number
    880.5025
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHARMACY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The product is a tamper evident, sterile seal used to cover opened pharmacy type drug containers. Such as vials, IV bottles, IV bags, etc.
    Device Description
    The device is a seal used to cover and protect the septum surface of a previously opened vial, IV bottle or bag. The seal serves as a tamper resistant seal in that, once the seal is removed, it can not be reattached to the septum.
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