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510(k) Data Aggregation

    K Number
    K080216
    Device Name
    SUPRAMESH EXTRA
    Manufacturer
    S. JACKSON, INC.
    Date Cleared
    2008-09-15

    (230 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    S. JACKSON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SupraMESH EXTRA™ nylon mesh is indicated for use as a hernia mesh and for plastic and reconstructive surgery.
    Device Description
    SupraMESH EXTRA™ nylon mesh is an 18" x 18" mesh panel woven from USP size 3-0 SUPRAMID EXTRA® nylon suture (FDA N80-838). The nylon used to manufacture this SUPRAMID EXTRA® nylon suture (FDA N80-838) is nylon 6. The knit description of the SupraMESH EXTRA™ nylon mesh panel is 1 x 1 Tricot stitch mesh.
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    K Number
    K973379
    Device Name
    STERILE SUPRAFOIL SMOOTH NYLON FOIL SHEETS
    Manufacturer
    S. JACKSON, INC.
    Date Cleared
    1997-09-25

    (17 days)

    Product Code
    FTM
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    S. JACKSON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Foil is intended for use by surgeons only where indicated for plastic and reconstructive surgery. The most widespread and standard use presently is for repair of orbital floor blow-out fractures in the eye. Its use is detailed in articles by Orkan Stasior, M.D., Merrill J. Reeh and James Tsujimura, M.D., J. Emery, M.D., G. von Noorden, M.D., and Donald Schlernitzauer, M.D. The foil is also used in Tympanoplasty in the middle ear as reference in...(the) article by James L. Sheehy, M.D. It has also been used to separate nerves and tendons from surrounding tissue to prevent adhesions during healing and then removed after healing is complete. It has been used to repair or replace dura matter in the skull, and in heavier thicknesses it has been attched to bones to give added strength where necessary.
    Device Description
    Sterile SupraFOIL Smooth Nylon Foil Sheets
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