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510(k) Data Aggregation

    K Number
    K081001
    Device Name
    PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTURE
    Manufacturer
    SUTURES INDIA PVT., LTD.
    Date Cleared
    2008-06-09

    (62 days)

    Product Code
    NEW
    Regulation Number
    878.4840
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUTURES INDIA PVT., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PD SYNTH IS SYNTHETIC ABSORBABLE (MONOFILAMENT POLYDIOXANONE) SURGICAL SUTURE, STERILE AND FLEXIBLE STRAND, PREPARED FROM THE POLYMER, POLYDIOXANONE, (HOMO POLYMER OF DI OXANONE 100%) AND IS INDICATED FOR USE IN SOFT TISSUE APPROXIMATION, INCLUDING USE IN OPHTHALMIC SURGERY, BUT NOT FOR USE IN CARDIO VASCULAR AND NEUROLOGICAL TISSUES
    Device Description
    PD Synth is a synthetic absorbable surgical suture, (Monofilament Polydioxanone). PD Synth is a sterile flexible monofilament thread, composed of the polymer, Polydioxanone. The sutures are inert, non collageneous and non antigenic. PD Synth is dyed with D&C Violet #2 and being monofilament it is uncoated
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    K Number
    K081002
    Device Name
    MONOGLYDE, ABSORBABLE (POLIGLECAPRONE 25) SUTURE
    Manufacturer
    SUTURES INDIA PVT., LTD.
    Date Cleared
    2008-06-09

    (62 days)

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

    SUTURES INDIA PVT., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MONOGLYDE IS A SYNTHETIC ABSORBABLE (POLIGLECAPRONE 25) SURGICAL SUTURE; STERILE FLEXIBLE STRAND, PREPARED AND SYNTHESIZED FROM THE MONOMERS, POLYGLYCOLIC ACID 75% AND CAPROLACTONE 25% AND IS INDICATED FOR USE IN GENERAL SOFT TISSUE APPROXIMATION, BUT NOT FOR USE IN OPHTHALMIC SURGERY, CARDIO-VASCULAR AND NEUROLOGICAL TISSUES
    Device Description
    MONOGLYDE is synthetic absorbable surgical suture, (Monofilament Poliglecaprone 25). Monoglyde is a sterile flexible monofilament thread, composed of Caprolactone. The sutures are inert, non collageneous and non antigenic. MONOGLYDE is dyed with D&C Violet #2 and it is available undyed also.
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    K Number
    K081003
    Device Name
    TRUSYNTH, ABSORBABLE (POLYGLACTIN 910) SUTURE
    Manufacturer
    SUTURES INDIA PVT., LTD.
    Date Cleared
    2008-06-09

    (62 days)

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

    SUTURES INDIA PVT., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K060018
    Device Name
    TRULENE MESH
    Manufacturer
    SUTURES INDIA PVT., LTD.
    Date Cleared
    2006-07-26

    (203 days)

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

    SUTURES INDIA PVT., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TRULENE MESH, NONABSORBABLE POLYPROPYLENE SURGICAL MESH IS INDICATED FOR USE IN HERNIA REPAIR AND OTHER FASCIAL DEFICIENCIES THAT REQUIRE THE ADDITION OF A REINFORCING OR BRIDGING MATERIAL TO OBTAIN THE DESIRED SURGICAL RESULT.
    Device Description
    Trulene Mesh is Nonabsorbable Polypropylene Surgical Mesh, produced by knitting filaments of extruded undyed Monofilament Polypropylene, a synthetic linear Poly olefin.
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