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510(k) Data Aggregation

    K Number
    K223126
    Device Name
    SurgiAid® Collagen Wound Dressing
    Manufacturer
    Maxigen Biotech, Inc.
    Date Cleared
    2023-10-11

    (373 days)

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

    Maxigen Biotech, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SurgiAid® Collagen Wound Dressing is indicated for use in patients who have surgical wounds, donor sites/grafts, podiatric wound, wound dehiscence, traumatic wounds, abrasions, lacerations, partial thickness burns or skin tears. SurgiAid® Collagen Wound Dressing can be applied to wounds with depth less than 0.3 cm.
    Device Description
    SurgiAid Collagen Wound Dressing (SurgiAid) is white, porous pliable and absorbable collagen wound dressing. It is fabricated by fibrous collagen matrix which is purified from bovine Achilles tendon. SurgiAid is pliable and can be applied easily to clean wound. The product is supplied in sterile, non-pyrogenic package, and is indicated for single use only.
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    K Number
    K100927
    Device Name
    SURGIAID
    Manufacturer
    MAXIGEN BIOTECH, INC.
    Date Cleared
    2011-02-02

    (303 days)

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

    MAXIGEN BIOTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SurgiAid Collagen Wound Dressing is intended for use in patients who have surgical wounds, donor sites/grafts podiatric wounds, wound dehiscence, traumatic wounds, abrasions, lacerations, partial thickness burns or skin tears. SurgiAid Collagen Wound Dressing can be applied to wounds with depth less than 0.3 cm.
    Device Description
    SugiAid Collagen Wound Dressing is white, porous, pliable and absorbable collagen wound dressings. It is fabricated by fibrous collagen matrix which is purified from bovine Achilles tendon. SugiAid is pliable and can be applied easily to clean wounds. The product is supplied in sterile, nonpyrogenic package, and is indicated for single use only.
    Ask a Question

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