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510(k) Data Aggregation

    K Number
    K103648
    Device Name
    COLLAGEN POWDER
    Manufacturer
    INNOCOLL PHARMACEUTICALS LTD
    Date Cleared
    2011-09-14

    (274 days)

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

    INNOCOLL PHARMACEUTICALS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Collagen Powder may be used for the management of wounds such as: - Diabetic ulcers - Venous ulcers - Pressure ulcers - Ulcers caused by mixed vascular etiologies - Full-thickness & partial thickness wounds - Abrasions - Traumatic wounds - 1st and 2nd degree burns - Dehisced surgical wounds - Exuding wounds
    Device Description
    Collagen Powder is a collagen matrix in powder form intended for application as a wound management device. The product is supplied sterile for single use only.
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    K Number
    K110388
    Device Name
    COLLACARE DENTAL
    Manufacturer
    INNOCOLL PHARMACEUTICALS LTD
    Date Cleared
    2011-08-09

    (180 days)

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

    INNOCOLL PHARMACEUTICALS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Collacare Dental is indicated for the management of oral wounds and sores, including: - denture sores - oral ulcers (non-infected or viral) - periodontal surgical wounds - suture sites - burns - surgical wounds and traumatic wounds
    Device Description
    Collacare Dental is a conformable collagen matrix manufactured from purified type I collagen derived from bovine Achilles tendon. Collacare Dental is supplied sterile and non-pyrogenic, in various sizes, and for single use only.
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