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510(k) Data Aggregation

    K Number
    K052550
    Device Name
    IMC SURGICAL GOWNS
    Manufacturer
    INTL. MEDSURG CONNECTION, INC.
    Date Cleared
    2005-11-17

    (62 days)

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

    INTL. MEDSURG CONNECTION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel from transfer of microorganisms, body fluids and particulate matter.
    Device Description
    Surgical Gowns including various sizes and material.
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    K Number
    K050538
    Device Name
    IMC DRAPES
    Manufacturer
    INTL. MEDSURG CONNECTION, INC.
    Date Cleared
    2005-06-07

    (97 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTL. MEDSURG CONNECTION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to be used as protective coverings used to isolate incision sites and protect against contamination during surgical procedures.
    Device Description
    International Medsurg Connection Surgical Drape.
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