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510(k) Data Aggregation

    K Number
    K102864
    Device Name
    84E SERIES SINGLE PLY WRAPPER
    Manufacturer
    LAC MAC, LTD.
    Date Cleared
    2011-01-14

    (106 days)

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

    LAC MAC, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lac-Mac Ltd. 84E Series Single Ply Wrappers are devices intended to be used to enclose another medical device that is to be sterilized by a health care provider. They are intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed medical device for at least 30 days. The Lac-Mac Ltd. 84E Series Single Ply Wrappers are provided nonsterile and must be processed before use. These wrappers may be reprocessed for a total of 100 uses when laundered and sterilized according to the label and instructions provided with the product. Reprocessing instructions are based on industrial laundering procedures and steam sterilization (prevacuum, 270°F, 4 minutes with 40 minutes drying time).
    Device Description
    Lac-Mac Ltd. 84E Series Single Ply Wrapper
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    K Number
    K092344
    Device Name
    LAC-MAC INNERBLOC LR SURGICAL GOWNS
    Manufacturer
    LAC MAC, LTD.
    Date Cleared
    2009-12-17

    (135 days)

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

    LAC MAC, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lac-Mac, Ltd, Innerbloc LR Surgical Gowns are reusable gowns that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
    Device Description
    Not Found
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    K Number
    K061491
    Device Name
    LAC-MAC INNERBLOC O.R. GOWN
    Manufacturer
    LAC MAC, LTD.
    Date Cleared
    2006-08-09

    (70 days)

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

    LAC MAC, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lac-Mac, Limited, InnerBloc® OR Surgical Gowns, based on the RePel Plus™ and GORE® Color Survice of the Art in the cours that are intended to be worn by health care The Lac-Mac, Limited, InnerBiolo OK Surgical Or his asse intended to be wort by health care LP Surgical Goven Pabric materials, are protect both the surgical patient world the operating room personnel from transfer of microorganisms, body filish, and patitulate matterial. For personnel from fransfer of of microolgamisms, "oody" history and processed and packaged.
    Device Description
    Lac-Mac, Limited, InnerBloc™ OR Surgical Gown
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    K Number
    K032631
    Device Name
    INNERBLOC LR SURGICAL GOWNS BASED ON GORE LR FABRIC (REUSABLE 100X)
    Manufacturer
    LAC MAC, LTD.
    Date Cleared
    2004-02-05

    (163 days)

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

    LAC MAC, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lac-Mac, Limited, InnerBloc® LR Surgical Gowns, based on the GORE® LR Fabric, are reusable gowns that are intended to be worn by health care personnel during surgical and other medical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. For manufacturing, processing, or repackaging, these gowns must be reprocessed and packaged.
    Device Description
    reusable gowns that are intended to be worn by health care personnel during surgical and other medical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
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    K Number
    K031362
    Device Name
    LAC-MAC LIMITED INNERBLOC VARIOUS O.R. DRAPE BASED ON THE REPEL, PLUS AND GORE SURGICAL BARRIER FABRIC MATERIALS
    Manufacturer
    LAC MAC, LTD.
    Date Cleared
    2003-05-30

    (99 days)

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

    LAC MAC, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lac-Mac Limited InnerBloc® O.R. Drapes based on the RePeL PLUS™ and GORE® Surgical Barrier Fabric Materials, are reusable protective patient coverings for isolating sites of surgical incisions from microbial or other contamination. For manufacturing, processing, or repackaging, these drapes must be reprocessed and packaged.
    Device Description
    Lac-Mac Limited InnerBloc® Various O.R. Drapes based on the RePeL PLUSTM and Gore® Surgical Barrier Fabric Materials
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    K Number
    K030536
    Device Name
    LAC-MAC LIMITED INNERBLOC O.R. GOWN
    Manufacturer
    LAC MAC, LTD.
    Date Cleared
    2003-05-06

    (75 days)

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

    LAC MAC, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lac-Mac Limited InnerBloc® O.R. Gowns based on the RePeL PLUS™ and GORE® Surgical Barrier Fabric Materials, are reusable gowns that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. For manufacturing, processing, or repackaging, these gowns must be reprocessed and packaged.
    Device Description
    reusable gowns that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
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