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510(k) Data Aggregation

    K Number
    K003015
    Device Name
    SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD
    Manufacturer
    SURGICAL SPECIALTIES CORP.
    Date Cleared
    2000-12-15

    (79 days)

    Product Code
    GAN
    Regulation Number
    878.4830
    Why did this record match?
    Product Code :

    GAN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K964072
    Device Name
    MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED
    Manufacturer
    ETHICON, INC.
    Date Cleared
    1996-12-18

    (68 days)

    Product Code
    GAN
    Regulation Number
    878.4830
    Why did this record match?
    Product Code :

    GAN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MONOCRYL suture, undyed is intended for use in general soft tissue approximation and/or ligation. Modified MONOCRYL sutures, undyed are indicated for soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
    Device Description
    MONOCRYL suture, undyed is a monofilament synthetic absorbable surgical suture prepared from a copolymer of glycolide and epsilon-caprolactone.
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    K Number
    K960653
    Device Name
    MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED)
    Manufacturer
    ETHICON, INC.
    Date Cleared
    1996-03-28

    (42 days)

    Product Code
    GAN
    Regulation Number
    878.4830
    Why did this record match?
    Product Code :

    GAN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MONOCRYL suture, dyed is intended for use in general soft tissue approximation and/or ligation. MONOCRYL sutures, dyed are indicated for soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
    Device Description
    MONOCRYL suture, dyed is a monofilament synthetic absorbable surgical suture prepared from a copolymer of glycolide and epsilon-caprolactone. MONOCRYL suture is dyed violet using D&C Violet No. 2.
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