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510(k) Data Aggregation

    K Number
    K033762
    Device Name
    SERRALAPG
    Manufacturer
    SERRAL, S.A. DE C.V.
    Date Cleared
    2004-03-15

    (104 days)

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

    SERRAL, S.A. DE C.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Serralapg™ Synthetic Surgical Absorbable Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in Ophthalmic, as a preliavascular and Neurological procedures.
    Device Description
    Not Found
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    K Number
    K020597
    Device Name
    SERRALGUT
    Manufacturer
    SERRAL, S.A. DE C.V.
    Date Cleared
    2002-08-14

    (173 days)

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

    SERRAL, S.A. DE C.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SERRALGUT™ sutures are indicated for use in general soft tissue approximation and/or ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
    Device Description
    Not Found
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    K Number
    K020902
    Device Name
    SERRALESTER
    Manufacturer
    SERRAL, S.A. DE C.V.
    Date Cleared
    2002-05-20

    (61 days)

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

    SERRAL, S.A. DE C.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SERRALESTER™ sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
    Device Description
    SERRALESTER™ Surgical Suture
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    K Number
    K020901
    Device Name
    SERRALSILK
    Manufacturer
    SERRAL, S.A. DE C.V.
    Date Cleared
    2002-04-26

    (37 days)

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

    SERRAL, S.A. DE C.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SERRALSILK™ sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
    Device Description
    Not Found
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    K Number
    K020146
    Device Name
    SERRALNYL
    Manufacturer
    SERRAL, S.A. DE C.V.
    Date Cleared
    2002-04-15

    (89 days)

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

    SERRAL, S.A. DE C.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SERRALNYL™ sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic and neurological procedures.
    Device Description
    Not Found
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    K Number
    K020265
    Device Name
    SERRALENE, MODEL CATALOG NO 1S
    Manufacturer
    SERRAL, S.A. DE C.V.
    Date Cleared
    2002-03-08

    (42 days)

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

    SERRAL, S.A. DE C.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SERRALENE™ sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
    Device Description
    Not Found
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