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510(k) Data Aggregation

    K Number
    K021043
    Device Name
    GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC
    Manufacturer
    GRAMSMED LLC
    Date Cleared
    2002-06-21

    (81 days)

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

    GRAMSMED LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Grams Absorbable Surgical Gut Suture (Plain and Chromic) is 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
    Grams Surgical gut suture (Plain and Chromic) is an absorbable sterile surgical suture 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.
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    K Number
    K010672
    Device Name
    MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE
    Manufacturer
    GRAMSMED LLC
    Date Cleared
    2001-05-18

    (73 days)

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

    GRAMSMED LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K003017
    Device Name
    GRAMSORB SYNTHETIC ABSORBABLE SUTURE
    Manufacturer
    GRAMSMED LLC
    Date Cleared
    2001-03-13

    (167 days)

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

    GRAMSMED LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K003590
    Device Name
    GRAMS POLYESTER NONABSORBABLE SUTURE
    Manufacturer
    GRAMSMED LLC
    Date Cleared
    2001-03-05

    (104 days)

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

    GRAMSMED LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002999
    Device Name
    GRAMS POLYPROPYLENE NONABSORBABLE SUTURE
    Manufacturer
    GRAMSMED LLC
    Date Cleared
    2000-12-18

    (83 days)

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

    GRAMSMED LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K003000
    Device Name
    GRAMS NYLON NONABSORBABLE SUTURE
    Manufacturer
    GRAMSMED LLC
    Date Cleared
    2000-12-18

    (83 days)

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

    GRAMSMED LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K003001
    Device Name
    GRAMS SILK NONABSORBABLE SUTURE
    Manufacturer
    GRAMSMED LLC
    Date Cleared
    2000-12-15

    (80 days)

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

    GRAMSMED LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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