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510(k) Data Aggregation

    K Number
    K984374
    Device Name
    SURGISORB
    Manufacturer
    SAMYANG CORP.
    Date Cleared
    1999-06-04

    (179 days)

    Product Code
    GAM
    Regulation Number
    878.4493
    Why did this record match?
    Applicant Name (Manufacturer) :

    SAMYANG CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    GENERAL SOFT TISSUE APPROXIMATION; INCLUDING USE IN OPHTHALMIC SURGERY, BUT NOT FOR USE IN CARDIOVASCULAR AND NEUROLOGICAL TISSUE.
    Device Description
    Survisorb brand absorbable suture is provided both dyed (D&C Viclet #2) and undyed (milk white), braided and monofiliment types and coated with polyceprolate and calcium sterate. Sizes offered are U.S.P. 8.0 through 2 (mstric equivalcht 0.4 through 5). Michaels. Polyglycolic acid. U.S.P. & polycaprolate and calcium sterate.
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    K Number
    K990363
    Device Name
    BIOMESH BIODEGRADABLE GTR BARRIER
    Manufacturer
    SAMYANG CORP.
    Date Cleared
    1999-04-09

    (63 days)

    Product Code
    NPK
    Regulation Number
    872.3930
    Why did this record match?
    Applicant Name (Manufacturer) :

    SAMYANG CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BioMesh® Biodegradable GTR Barrier is intended for use in the surgical management and treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures. Indications for Use: BioMesh® Biodegradable GTR Barrier is indicated for use in the treatment of the following specific conditions: 1. Two or three wall vertical defects. 2. Class II furcations. 3. Circumferrential defects. 4. Recession type defects. 5. Dehisence defects associated with dental implants
    Device Description
    BioMesh® Biodegradable GTR Barrier is provided as a single membrane type, but in a variety of precut shapes and sizes. Shapes and sizes. As noted on the graphic representation at the left, five different shapes are offered. The BioMesh® Biodegradable GTR Barrier is shape optimized to provide a ready made pattern well suited to the selected operative site needing a minimum of surgeon modification. If desired, the surgeon can trim any of the available shapes to fit unique or unusual circumstances. The BioMesh® Biodegradable GTR Barrier is made from polyglycolic acid with a coating of polylactic acid + polylactic glycolic acid copolymer. The membrane is constructed with interconnective pores with an embossed surface.
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