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510(k) Data Aggregation

    K Number
    K092257
    Device Name
    JALOSKIN
    Manufacturer
    FIDIA ADVANCED BIOPOLYMERS SRL
    Date Cleared
    2010-01-26

    (182 days)

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

    FIDIA ADVANCED BIOPOLYMERS SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    JALOSKIN is indicated for the management of superficial moderately exuding wounds including pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, skin tears) and first and second degree burns.
    Device Description
    JALOSKIN is a semi-permeable, transparent film dressing, composed of HYAFF® 11, a benzyl ester of hyaluronic acid. The hyaluronic acid is derived from bacterial fermentation.
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    K Number
    K073251
    Device Name
    HYALOMATRIX PA
    Manufacturer
    FIDIA ADVANCED BIOPOLYMERS SRL
    Date Cleared
    2007-12-14

    (25 days)

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

    FIDIA ADVANCED BIOPOLYMERS SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HYALOMATRIX® is indicated for the management of wounds including: partial and full-thickness wounds; second-degree burns; pressure ulcers; venous ulcers; diabetic ulcers; chronic vascular ulcers; tunneled/undetermined wounds; surgical wounds (donor sites/grafts, post-Moh's surgery , post-laser surgery, podiatric, wound dehiscence); trauma wounds (abrasions, lacerations, skin tears); and draining wounds. The device is intended for one-time use.
    Device Description
    HYALOMATRIX is a bilayered, sterile, flexible, and conformable wound dressing that acts as an advanced wound care device. It is comprised of a nonwoven pad entirely composed of HYAFF 11, a benzyl ester of hyaluronic acid, and a semipermeable silicone membrane, which controls water vapor loss, provides a flexible covering for the wound surface, and adds increased tear strength to the device. The HYAFF 11 wound contact layer biodegradable matrix acts as a scaffold for cellular invasion and capillary growth.
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    K Number
    K001508
    Device Name
    LASERSKIN DRESSING
    Manufacturer
    FIDIA ADVANCED BIOPOLYMERS SRL
    Date Cleared
    2001-07-25

    (436 days)

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

    FIDIA ADVANCED BIOPOLYMERS SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K003855
    Device Name
    HYALOMATRIX CO
    Manufacturer
    FIDIA ADVANCED BIOPOLYMERS SRL
    Date Cleared
    2001-07-03

    (202 days)

    Product Code
    KHJ
    Regulation Number
    874.3620
    Why did this record match?
    Applicant Name (Manufacturer) :

    FIDIA ADVANCED BIOPOLYMERS SRL

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

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