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510(k) Data Aggregation

    K Number
    K123034
    Device Name
    VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED
    Manufacturer
    UNILENE S.A.C.
    Date Cleared
    2013-05-28

    (242 days)

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

    UNILENE S.A.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The nonabsorbable sutures (Monofilament Nylon, Polypropylene and Silk) are indicated for use in soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
    Device Description
    Not Found
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    K Number
    K100780
    Device Name
    VITAL SUTURES, SUTUREX, CIRUGIA PERUANA
    Manufacturer
    UNILENE S.A.C.
    Date Cleared
    2010-12-14

    (270 days)

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

    UNILENE S.A.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The absorbable sutures (Polydioxanone, Polyglactin and Polyglycolic Acid) are indicated for use in soft tissue approximation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures. The absorbable sutures (Polyglecaprone) are indicated for use in soft tissue approximation, but not for use in ophthalmic procedures, cardiovascular and neurological procedures.
    Device Description
    Not Found
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