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510(k) Data Aggregation

    K Number
    K992094
    Device Name
    GILTECH PLUS HYDROGEL SKIN DRESSING
    Manufacturer
    GILTECH PLUS, INC.
    Date Cleared
    1999-09-17

    (88 days)

    Product Code
    NAE, MGQ
    Regulation Number
    878.4022
    Why did this record match?
    Applicant Name (Manufacturer) :

    GILTECH PLUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Giltech Plus Hydrogel Wound Dressing is intended to be used in the management of. 1. Minor burns 2. Decubitus ulcers 3. Superficial lacerations, cuts and abrasions 4. Postoperative incisions 5. Sunburn
    Device Description
    This hydrogel retains cold temperature. Its' high specific heat, due to high water content, allows it to have a cooling effect.
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    K Number
    K992005
    Device Name
    GILTECH PLUS TRANSPARENT DRESSING
    Manufacturer
    GILTECH PLUS, INC.
    Date Cleared
    1999-09-03

    (80 days)

    Product Code
    MGP
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    GILTECH PLUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Giltech Plus Transparent Dressing is indicated for the management of moderately draining wounds such as: (a) Stage I and II pressure sores (decubitus ulcers) (b) Skin tears or lacerations (c) Superficial burns and abrasions (d) Surgical wounds
    Device Description
    Transparent Dressing
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    K Number
    K983624
    Device Name
    GILTECH PLUS CONNECTING TUBE SET
    Manufacturer
    GILTECH PLUS, INC.
    Date Cleared
    1999-03-18

    (154 days)

    Product Code
    KDH
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    GILTECH PLUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Giltech Plus Connecting Tube Sets will consist of: (a) Insufflation Tubing Sets (b) Suction / Irrigation Sets (c) Urinary Extension Tubing (d) Tubing Sets necessary to connect two devices, however never to be used to transmit a gas or a liquid for intravenous or intramuscular transmission.
    Device Description
    Not Found
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