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510(k) Data Aggregation

    K Number
    K961925
    Device Name
    POLYESTER NONABSORBABLE SURGICAL SUTURES USP
    Manufacturer
    R.K. MEDICAL, L.L.C.
    Date Cleared
    1996-07-29

    (73 days)

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

    R.K. MEDICAL, L.L.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The polyester nonabsorbable surgical sutures USP are indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.
    Device Description
    Polyester nonabsorbable surgical sutures USP, manufactured by R.K. Medical, L.L.C. are equivalent to Ti-cron* polyester nonabsorbable surgical suture USP manufactured by Davis & Geck. The polyester nonabsorbable surgical sutures USP manufactured by R.K. Medical and Davis & Geck are braided and coated with silicone. The R.K. Medical polyester suture is dyed green (D&C Green #6). Davis & Geck's Ti-cron* is dyed blue (D&C Blue #6).
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    K Number
    K961931
    Device Name
    PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP
    Manufacturer
    R.K. MEDICAL, L.L.C.
    Date Cleared
    1996-07-29

    (73 days)

    Product Code
    GAL
    Regulation Number
    878.4830
    Why did this record match?
    Applicant Name (Manufacturer) :

    R.K. MEDICAL, L.L.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Plain and chromic gut surgical sutures USP are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
    Device Description
    Plain and chromic gut surgical sutures USP manufactured by R.K. Medical, L.L.C. are equivalent to plain and chromic gut surgical sutures manufactured by Davis & Geck. These sutures are absorbable, sterile surgical sutures composed of purified connective tissue (mostly collagen) derived from either the serosal layer of beef (bovine) or the submucosal fibrous layer of sheep (ovine) intestines. The plain and chromic gut sutures are packaged in packing fluid composed of isopropanol, water, and triethanolamine. R.K. Medical plain and chromic gut surgical sutures are sterilized by gamma irradiation.
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    K Number
    K961389
    Device Name
    POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES
    Manufacturer
    R.K. MEDICAL, L.L.C.
    Date Cleared
    1996-06-18

    (69 days)

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

    R.K. MEDICAL, L.L.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Polypropylene nonabsorbable surgical sutures, USP are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
    Device Description
    Polypropylene nonabsorbable surgical sutures, USP, manufactured by R. K. Medical L. L. C. are equivalent to Surgilene™ polypropylene nonabsorbable surgical sutures manufactured by Davis+Geck. The Polypropylene sutures manufactured by R. K. Medical and D+G are monofilament and are dyed blue [ phthalocyaninato (2--) | copper .
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    K Number
    K960327
    Device Name
    NYLON NOABSORBABLE SURGICAL SUTURES USP
    Manufacturer
    R.K. MEDICAL, L.L.C.
    Date Cleared
    1996-03-04

    (40 days)

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

    R.K. MEDICAL, L.L.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The nylon nonabsorbable sutures, USP are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurologica1 procedures.
    Device Description
    Nylon nonabsorbable surgical sutures, USP, manufactured by R. K. Medical L. L. C. are equivalent to nylon nonabsorbable surgical sutures manufactured by Davis + Geck. The nylon sutures manufactured by R. K. Medica1 and D+G can be monofilament or braided, coated with silicone, or wax, or uncoated, dyed black or blue or undyed.
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    K Number
    K960328
    Device Name
    SILK NONABSORBABLE SURGICAL SUTURES USP
    Manufacturer
    R.K. MEDICAL, L.L.C.
    Date Cleared
    1996-03-04

    (40 days)

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

    R.K. MEDICAL, L.L.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The silk nonabsorbable sutures, USP are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures .
    Device Description
    Silk nonabsorbable surgical sutures, USP, manufactured by R. K. Medical L. L. C. are equivalent to silk nonabsorbable surgical sutures manufactured by Davis + Geck. The silk sutures manufactured by R. K. Medical and D+G can be twisted, or braided, coated with silicone, or wax, or uncoated, dyed black (Logwood) or undyed.
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