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510(k) Data Aggregation

    K Number
    K041511
    Device Name
    TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE
    Manufacturer
    SUTURES INDIA PRIVATE LIMITED
    Date Cleared
    2005-06-03

    (361 days)

    Product Code
    GAW
    Regulation Number
    878.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUTURES INDIA PRIVATE LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TRULENE™ Non-absorbable Polypropylene Surgical Suture is indicated for use in soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.
    Device Description
    TRULENE Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene. The polypropylene surgical suture meets united states pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it is dyed with an FDA approved color additive (Phthalocyaninato (2-) copper); and the suture is provided with a standard needle attached.
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    K Number
    K041514
    Device Name
    TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE
    Manufacturer
    SUTURES INDIA PRIVATE LIMITED
    Date Cleared
    2005-06-03

    (361 days)

    Product Code
    GAP
    Regulation Number
    878.5030
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUTURES INDIA PRIVATE LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TRUSILK" Non-absorbable Silk Surgical Suture is indicated for use in soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.
    Device Description
    TRUSH.K is a natural nonabsorbable silk surgical suture, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Natural Nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for "Nonabsorbable Surgical Suture" . Natural Nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive. It will be available with and with out a standard needle attached.
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    K Number
    K041510
    Device Name
    TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE
    Manufacturer
    SUTURES INDIA PRIVATE LIMITED
    Date Cleared
    2005-06-02

    (360 days)

    Product Code
    GAR
    Regulation Number
    878.5020
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUTURES INDIA PRIVATE LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TRULON™ Non-absorbable Polyamide Surgical Suture is indicated for use in soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.
    Device Description
    TRULON Nonabsorbable Polyamide Surgical Suture is a nonabsorbable, sterile, flexible monofilament thread composed of long chain aliphatic polymers Nylon 6 and Nylon 6.6. The suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture. The suture may be dyed Logwood Extract, C.175290 conforming to 21 CFR 73.1410. The suture may be provided with or without a standard needle attached.
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    K Number
    K041512
    Device Name
    NONABSORBABLE (POLYETHYLENE TEREPHTHALATE) SURGICAL SUTURE
    Manufacturer
    SUTURES INDIA PRIVATE LIMITED
    Date Cleared
    2005-06-02

    (360 days)

    Product Code
    GAT
    Regulation Number
    878.5000
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUTURES INDIA PRIVATE LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TRUBOND™ Non-absorbable Polyethylene Terephthalate Surgical Suture is indicated for use in soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.
    Device Description
    "TRUBOND" is a Nonabsorbable (Poly cthylene terephthalate) Surgical Suture, is a multifilament nonabsorbable, sterile, flexible thread prepared from fibres of high molecular weight, long chain, linear polyesters having recurrent aromatic rings as an integral component. Polycster Nonabsorbable Surgical Suture meets united states "TRUBOND" (U.S.P.) requirements as described in the U.S.P monograph for pharmacopcia "Nonabsorbable surgical sutures"; it is coated with a highly adherent biologically inert polybutylate and it may be undyed or dyed with D&C green no-5, conforming to U.S.Code of Federal Regulations 21 CFR 74.1205 or with Logwood extract black, conforming to U.S.Code of Federal Regulations 21 CFR 73.1410 . The suture may be provided with or without a standard needle attached.
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    K Number
    K041515
    Device Name
    TRUGLYDE ABSORBABLE POLYGLYCOLIC ACID SURGICAL SUTURE
    Manufacturer
    SUTURES INDIA PRIVATE LIMITED
    Date Cleared
    2005-04-08

    (305 days)

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

    SUTURES INDIA PRIVATE LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TRUGLYDE Absorbable Polyglycolic Acid Surgical Suture is indicated for use in soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological procedures
    Device Description
    Absorbable Surgical Suture,Synthetic (Polyglycolic Acid)
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