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510(k) Data Aggregation

    K Number
    K043526
    Device Name
    SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC
    Manufacturer
    NOBLE FIBER TECHNOLOGIES, INC.
    Date Cleared
    2005-03-10

    (79 days)

    Product Code
    LGF
    Regulation Number
    888.5940
    Why did this record match?
    Product Code :

    LGF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K973417
    Device Name
    CLINITEX STOCKINETTE
    Manufacturer
    CLINITEX MEDICAL CORP.
    Date Cleared
    1997-12-09

    (90 days)

    Product Code
    LGF
    Regulation Number
    888.5940
    Why did this record match?
    Product Code :

    LGF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Clinitex® Stockinette is a tubular textile used to form the first protective layer (base) of an orthopedic cast below the cast padding and cast tape. The polyester material help repel water and dry rapidly.
    Device Description
    Clinitex® Stockinette is a tubular textile used to form the first protective layer (base) of an orthopedic cast below the cast padding and cast tape. The polyester material help repel water and dry rapidly.
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    K Number
    K973420
    Device Name
    CLINITEX CAST PADDING
    Manufacturer
    CLINITEX MEDICAL CORP.
    Date Cleared
    1997-12-09

    (90 days)

    Product Code
    LGF, DAT
    Regulation Number
    888.5940
    Why did this record match?
    Product Code :

    LGF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Clinitex Cast Padding is a thin mat of interlocked textile fibers used to form a protective pad of multiple layers between the stockinette and orthopedic cast. This protective pad protects the skin, ensures that bony prominences are adequately padded to prevent undesired pressure and/or chafing from the cast and compensates for normal amounts of swelling to the affected area immediately after the injury. The polyester fibers help repel water and dry rapidly.
    Device Description
    Clinitex Cast Padding is a thin mat of interlocked textile fibers used to form a protective pad of multiple layers between the stockinette and orthopedic cast.
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    K Number
    K955320
    Device Name
    PROTEC COTTON PADDING BANDAGE
    Manufacturer
    DERIVADAS DEGASA S.A. DE C.V.
    Date Cleared
    1996-01-26

    (67 days)

    Product Code
    LGF
    Regulation Number
    888.5940
    Why did this record match?
    Product Code :

    LGF

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

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