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510(k) Data Aggregation

    K Number
    K070432
    Device Name
    GENERAL SURGERY DRAPES
    Manufacturer
    WELMED INC.
    Date Cleared
    2007-09-24

    (223 days)

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

    WELMED INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Disposable sterile drapes are used in the operating room as a protective covering, for both patient and operating room staff, from the transfer of body fluids, micro-organisms and particulates. Drapes provided as sterile and non-sterile. Non-sterile surgical drapes are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Drapes are to be sold directly to users after EtO sterilization validation to ISO 11135.
    Device Description
    Not Found
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    K Number
    K070936
    Device Name
    WELMED HYPODERMIC SYRINGE
    Manufacturer
    WELMED INC.
    Date Cleared
    2007-07-16

    (104 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    WELMED INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Welmed, Inc. piston syringes is to inject fluids into or withdraw fluids from the body.
    Device Description
    The Welmed, Inc. Syringe is a device intended for medical purposes, consisting of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male Luer Lock connector (nozzle) for attaching the female Luer connector (hub) of a hypodermic single lumen needle, or for attaching other devices with a female Luer.
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    K Number
    K070431
    Device Name
    WELMED, INC. SURGICAL GOWNS
    Manufacturer
    WELMED INC.
    Date Cleared
    2007-05-24

    (100 days)

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

    WELMED INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Disposable gowns are used in the OR as a protective covering, for operating room staff, from the transfer of body fluids and particulates. Gowns provided as sterile and non-sterile. Non-sterile surgical gowns are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.
    Device Description
    Not Found
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