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510(k) Data Aggregation

    K Number
    K970721
    Device Name
    DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM
    Manufacturer
    JOHNSON & JOHNSON MEDICAL, INC.
    Date Cleared
    1997-03-21

    (22 days)

    Product Code
    MCY
    Regulation Number
    880.5075
    Why did this record match?
    Product Code :

    MCY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DYNA-FLEX* Multi-Layer Compression System is indicated for the management of venous leg ulcers and related conditions. The compression system may be used on patients with an ankle circumference of 18 cm or larger (padded). Compression data indicates that the DYNA-FLEX* Multi-Layer Compression System provides sustained compression for up to seven days at both the ankle and below the knee, when used according to package insert directions. The DYNA-FLEX Multi-Layer Compression System should not be used on diabetic patients with advanced small vessel disease, patients with lymphadema as a result of cancer, or on patients with an ankle:brachial index (ABI) of less than 0.8 . Doppler ultrasound is recommended to rule out arterial disease.
    Device Description
    The DYNA-FLEX* Multi-Layer Compression System is a kit that is comprised of one wound dressing component and three bandage layers for the management of venous leg ulcers and related conditions and is packaged in a polyethylene resealable bag. The description of each of these components/bandage layers is as follows: - The wound dressing component is the ADAPTIC* Non-Adhering Dressing (Sterile). . This non-adherent 5" x 9 " pad is impregnated with a petrolatum emulsion and is packaged in a polyester polyethylene film that is heat sealed prior to sterilization. - The first bandage layer is the DYNA-FLEX* Layer One (Padding/Absorption Layer). . This polyurethane stretch foam/cotton wrap (non-sterile) is packaged in a polyurethane shrink wrap. Layer One is supplied in a 4" x 156" roll. (unstretched). - . The second bandage layer is the DYNA-FLEX* Layer Two (Compression Bandage). This non-sterile compression wrap is comprised of absorbent yarns knitted with elastomeric and nylon yarns and is packaged in a polyurethane shrink wrap. Layer Two is supplied in a 4" x 90" roll (unstretched). To assist the healthcare professional in wrapping, this bandage layer is knitted with a rectangle design, such that as the bandage is extended it will change to a square design thus indicating a satisfactory compression range. - . The third bandage layer is the DYNA-FLEX* Layer Three (Cohesive Compression Bandage). This non-sterile cohesive compression bandage is comprised of a nonwoven . fabric with spandex elastic yarns bonded with a natural rubber cohesive latex based system. Layer Three is supplied in a 4" x 216" roll (stretched).
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    K Number
    K963719
    Device Name
    CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY
    Manufacturer
    GRAND MEDICAL PRODUCTS
    Date Cleared
    1996-11-27

    (72 days)

    Product Code
    MCY
    Regulation Number
    880.5075
    Why did this record match?
    Product Code :

    MCY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K960585
    Device Name
    WOUND CARE COMPRESSION SYSTEM (WCCS)
    Manufacturer
    SUNCOAST MEDICAL PRODUCTS, INC.
    Date Cleared
    1996-04-26

    (74 days)

    Product Code
    MCY
    Regulation Number
    880.5075
    Why did this record match?
    Product Code :

    MCY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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