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510(k) Data Aggregation

    K Number
    K984422
    Device Name
    STERILE BACK SURGICAL GOWN WITH HAND TOWEL
    Manufacturer
    MEDICAL STERILIZATION, INC.
    Date Cleared
    1999-04-02

    (113 days)

    Product Code
    FYA
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL STERILIZATION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Surgical Gown is intended to be worn by operating room personnel during surgical procedures to protect both the surqical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
    Device Description
    Sterile Back Surgical Gown with Hand Towel
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