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510(k) Data Aggregation

    K Number
    K970988
    Device Name
    FAR-EAST BOUFFANT CAPS
    Manufacturer
    FAR EAST SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD
    Date Cleared
    1997-07-10

    (114 days)

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

    **FAR EAST SCIENCE **& TECHNOLOGY DEVELOPMENT CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Far-East Bouffant Caps are disposable devices, intended for medical purposes, that are worn by operating room personnel during surgical procedures to protect form surgical patient and operating room personnel from Burgioal patient and open commons and particulate materials.
    Device Description
    Far-East Bouffant Caps are disposable devices, intended for medical purposes, that are worn by operating room personnel during surgical procedures to protect form surgical patient and operating room personnel from Burgioal patient and open commons and particulate materials.
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    K Number
    K971191
    Device Name
    FAR-EAST SHOE COVERS
    Manufacturer
    FAR EAST SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD
    Date Cleared
    1997-07-10

    (101 days)

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

    **FAR EAST SCIENCE **& TECHNOLOGY DEVELOPMENT CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Far-East Shoe Covers are disposable and single used devices, intended for medical purposes, that are worn on to cover the shoes of all personnel during the general medical procedures, or surgical procedures to protect the medical personnel, or surgical personnel from transfer of bacteria, micro-organisms and particulate material.
    Device Description
    Far-East Shoe Covers are disposable and single used devices, intended for medical purposes, that are worn on to cover the shoes of all personnel during the general medical procedures, or surgical procedures to protect the medical personnel, or surgical personnel from transfer of bacteria, micro-organisms and particulate material.
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    K Number
    K971702
    Device Name
    FAR-EAST BARRIER GOWNS
    Manufacturer
    FAR EAST SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD
    Date Cleared
    1997-07-08

    (61 days)

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

    **FAR EAST SCIENCE **& TECHNOLOGY DEVELOPMENT CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Isolation for Far-East Barrier Gowns Far-East Barrier Gowns are disposable and single use devices, for general medical purposes, that are worn on to intended protect the isolation patients, medical staffs and visitors from transfer of micro-organisms, body fluids and particulate material during the general medical procedures and patient room visits in hospitals. These devices are non-sterile, not intended to be used by O. R. personnel for surgical procedures.
    Device Description
    Far-East Barrier Gowns are disposable and single use devices, for general medical purposes, that are worn on to intended protect the isolation patients, medical staffs and visitors from transfer of micro-organisms, body fluids and particulate material during the general medical procedures and patient room visits in hospitals. These devices are non-sterile, not intended to be used by O. R. personnel for surgical procedures.
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