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510(k) Data Aggregation

    K Number
    K023136
    Device Name
    OLEEVA FABRIC
    Manufacturer
    BIO MED SCIENCES, INC.
    Date Cleared
    2002-10-16

    (26 days)

    Product Code
    MDA
    Regulation Number
    878.4025
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO MED SCIENCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Oleeva Fabric is indicated for the management of hypertrophic scars and keloids. Consistent use of Oleeva Fabric can reduce hypertrophic scaring and keloid formation resulting from surgical or traumatic injury of the skin. Oleeva Fabric may be useful as a prophylaxis after surgical or traumatic dermal injury to aid in the prevention of hypertrophic scars and keloids.
    Device Description
    Oleeva Fabric is used topically to reduce hypertrophic scars and keloids. Consistent use of Oleeva may minimize scars resulting from traumatic or surgical injuries. Oleeva can reduce existing scars, and may be used after traumatic or surgical injury to aid in the prevention of new scars.
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    K Number
    K002109
    Device Name
    OLEEVA FOAM
    Manufacturer
    BIO MED SCIENCES, INC.
    Date Cleared
    2000-08-31

    (50 days)

    Product Code
    MDA
    Regulation Number
    878.4025
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO MED SCIENCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K990042
    Device Name
    SILON DUAL-DRESS
    Manufacturer
    BIO MED SCIENCES, INC.
    Date Cleared
    1999-03-19

    (72 days)

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

    BIO MED SCIENCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the management of partial and full thickness wounds including the following: - Second Degree Burns - Skin Graft Donor Sites - Autograft Sites - Abrasions - Lacerations - Stage II III Chronic Wounds (Venous Stasis, Decubitus & Diabetic) - Skin Tears
    Device Description
    Silon® Dual-Dress™ is a single dressing with two different sides. One side consists of an open-celled hydrophilic foam. The other side consists of a non-adherent semi-occlusive film. The semi-occlusive film is perforated to allow wound exude to wick away from the wound. With the foam side of the dressing down against the wound, the product provides an adhesive surface for difficult fixation conditions. With the film side down, the dressing provides a non-adherent covering for fragile and sensitive wounds. One side of the dressing is clearly marked with the product name and the words "Foam on Other Side" printed with a biocompatible ink.
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    K Number
    K982036
    Device Name
    SILON SCAR STRIPS
    Manufacturer
    BIO MED SCIENCES, INC.
    Date Cleared
    1998-08-06

    (57 days)

    Product Code
    MDA
    Regulation Number
    878.4025
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO MED SCIENCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Silon Scar Strips are indicated for the management of hypertrophic scars and keloids. Consistent use of Silon Scar Strips can reduce hypertrophic scaring and keloid formation resulting from surgical or traumatic injury of the skin. Silon Scar Strips may be useful as a prophylaxis after surgical or traumatic dermal injury to aid in the prevention of hypertrophic scars and keloids.
    Device Description
    The Applicant presently markets Silon-SES® Silicone Elastomer Sheeting for the management of hypertrophic scars and keloids. The new product does not introduce any new concepts in silicone scar management products. Silon-SES is presently labeled for sale by or on the order of a physician. The Applicant hereby intends to remove this restriction and offer the product directly to consumers "over-the-counter."
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