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510(k) Data Aggregation

    K Number
    K974891
    Device Name
    ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013
    Manufacturer
    ACUTEK ADHESIVE SPECIALTIES, INC.
    Date Cleared
    1998-10-21

    (295 days)

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

    ACUTEK ADHESIVE SPECIALTIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hydrocolloid Dressing is intended for applications where gentle adhesion to the skin is desirable. Also, the dressing is intended for the management of lightly to heavily exudating wounds by absorbing exudate and by maintaining a moist wound environment. The moist wound environment supports autolytic debridement. The dressing backing allows for gas exchange. The dressing is indicated for use in the following types of wounds: Venous stasis ulcers, pressure ulcers, surgical incision sites, and minor burns.
    Device Description
    Acutek Hydrocolloid Wound Dressing, TIB 197013
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    K Number
    K974890
    Device Name
    ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 997002
    Manufacturer
    ACUTEK ADHESIVE SPECIALTIES, INC.
    Date Cleared
    1998-10-13

    (287 days)

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

    ACUTEK ADHESIVE SPECIALTIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hydrocolloid Dressing is intended for the management of lightly to moderately exudating wounds by absorbing exudate and by maintaining a moist wound environment. The moist wound environment supports autolytic debridement. The dressing backing allows for gas exchange. The dressing is indicated for use in the following types of wounds: venous stasis ulcers, pressure ulcers, surgical incision sites, and minor burns.
    Device Description
    Not Found
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    K Number
    K974892
    Device Name
    ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197012
    Manufacturer
    ACUTEK ADHESIVE SPECIALTIES, INC.
    Date Cleared
    1998-10-13

    (287 days)

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

    ACUTEK ADHESIVE SPECIALTIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hydrocolloid Dressing is intended for applications where gentle adhesion to the skin is desirable. The dressing is also intended for the management of lightly to moderately exudating wounds by absorbing exudate and by maintaining a moist wound environment. The moist wound environment supports autolytic debridement. The dressing backing allows for gas exchange. The dressing is indicated for use in the following types of wounds: venous stasis ulcers, pressure ulcers, surgical incision sites, and minor burns.
    Device Description
    Not Found
    Ask a Question
    K Number
    K962698
    Device Name
    ACUTEK'S CLEARPASAGE
    Manufacturer
    ACUTEK ADHESIVE SPECIALTIES, INC.
    Date Cleared
    1996-09-09

    (84 days)

    Product Code
    LWF
    Regulation Number
    874.3900
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACUTEK ADHESIVE SPECIALTIES, INC.

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

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