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510(k) Data Aggregation

    K Number
    K022666
    Device Name
    PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P.
    Manufacturer
    ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.
    Date Cleared
    2002-10-09

    (61 days)

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

    ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PDO (Polydioxanone) Monofilament Synthetic Absorbable Sutures U.S.P. are indicated for use in general soft tissue approximation and/or ligation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. PDO is not indicated for use in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are useful where an absorbable suture with extended wound support (up to six weeks) is desirable.
    Device Description
    The PDO (Polydioxanone) Monofilament Synthetic Absorbable Sutures, U.S.P. manufactured by ARC Medical and CP Medical are monofilament suture composed of a Poly(p-dioxanone) acid, un-dyed or dyed with D&C Violet No. 2.
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    K Number
    K022664
    Device Name
    PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P.
    Manufacturer
    ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.
    Date Cleared
    2002-09-10

    (32 days)

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

    ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PGA (polyglycolic) Synthetic Absorbable Sutures U.S.P. are indicated for use in general soft tissue approximation; including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.
    Device Description
    The PGA (Polyglycolic) Synthetic Absorbable Sutures, U.S.P. manufactured by ARC Medical and SAMYANG Corporation are braided and monofilament types and coated with polycaprolate and calcium stearate and are un-dyed with D&C Violet No. 2.
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    K Number
    K000541
    Device Name
    SILK NONABSORBABLE SURGICAL SUTURES, USP
    Manufacturer
    ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.
    Date Cleared
    2000-04-28

    (71 days)

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

    ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000542
    Device Name
    PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP
    Manufacturer
    ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.
    Date Cleared
    2000-04-28

    (71 days)

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

    ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000537
    Device Name
    POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP
    Manufacturer
    ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.
    Date Cleared
    2000-04-27

    (70 days)

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

    ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000539
    Device Name
    NYLON NONABSORBABLE SURGICAL SUTURES, USP
    Manufacturer
    ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.
    Date Cleared
    2000-04-27

    (70 days)

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

    ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000540
    Device Name
    POLYESTER NONABSORBABLE SURGICAL SUTURES, USP
    Manufacturer
    ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.
    Date Cleared
    2000-04-27

    (70 days)

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

    ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.

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

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