Search Filters

Search Results

Found 4 results

510(k) Data Aggregation

    K Number
    K080796
    Device Name
    SRI LP DRAPE
    Date Cleared
    2008-11-17

    (242 days)

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

    SRI/SURGICAL EXPRESS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SRI/Surgical Express SRI LP Drapes are reusable drapes, including back table covers (model numbers 1616, 1822, 3010, 3015, 3020, 3025, 3030, and 6113), mayo stand covers (model numbers 1247C, 3000, 30004, 3006, and 6247A), and drape sheets (model numbers 3870, 3871, 3872, and 3873) that are intended to be used by health care 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
    Reusable drapes, including back table covers (model numbers 1616, 1822, 3010, 3015, 3020, 3025, 3030, and 6113), mayo stand covers (model numbers 1247C, 3000, 30004, 3006, and 6247A), and drape sheets (model numbers 3870, 3871, 3872, and 3873).
    Ask a Question

    Ask a specific question about this device

    K Number
    K080707
    Device Name
    SRI PLR GOWN
    Date Cleared
    2008-11-13

    (246 days)

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

    SRI/SURGICAL EXPRESS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SRI/Surgical Express SRI Level III 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
    SRI/Surgical Express Level III Gowns are reusable gowns.
    Ask a Question

    Ask a specific question about this device

    K Number
    K080723
    Device Name
    SRI LP GOWN
    Date Cleared
    2008-11-13

    (246 days)

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

    SRI/SURGICAL EXPRESS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SRI/Surgical Express SRI Level IV Gowns are reusable gowns that arc 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
    SRI/Surgical Express Level IV Gowns
    Ask a Question

    Ask a specific question about this device

    K Number
    K023635
    Device Name
    SRI/SURGICAL EXPRESS SP REUSABLE SURGICAL GOWN
    Date Cleared
    2002-11-18

    (20 days)

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

    SRI/SURGICAL EXPRESS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Surgical gowns are devices that are intended to be worn by health care personnel during surgical or other Ourgiour gowns are a vice that and the wearer from transfer of microorganisms, body fluids, and particulate material.
    Device Description
    reusable surgical ' gown manufactured with the W.L. Gore ASSIST™ medical fabric in the Critical Zones.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1