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510(k) Data Aggregation

    K Number
    K023210
    Device Name
    SEEDLINKS, MODELS 70301, 70302, 70303
    Date Cleared
    2003-03-28

    (183 days)

    Product Code
    Regulation Number
    892.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOURCETECH MEDICAL, L.L.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SeedLinks™ are indicated for use in brachytherapy source spacing and linking in brachytherapy procedures.
    Device Description
    Not Found
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    K Number
    K991881
    Device Name
    125-IMPLANT SEEDS, MODEL STM1250
    Date Cleared
    2000-03-16

    (288 days)

    Product Code
    Regulation Number
    892.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOURCETECH MEDICAL, L.L.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    125 Implant Seeds are indicated for permanent interstitial treatment of selected localized tumors such as head and neck, lung, pancreas and early stage prostate. 125 mplant Seeds may be used in superficial, intraabdominal or intra-thoracic locations. 125 Implant Seeds may also be used in the treatment of residual tumors following completion of external beam radiation therapy and for other recurrent tumors.
    Device Description
    Not Found
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    K Number
    K991280
    Device Name
    125 IMPLANT SEEDS, MODEL STM1251
    Date Cleared
    1999-10-20

    (189 days)

    Product Code
    Regulation Number
    892.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOURCETECH MEDICAL, L.L.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    125 Implant Seeds are indicated for permanent interstitial treatment of selected localized tumors such as head and neck, lung, pancreas and early stage prostate. 125 Implant Seeds may be used in superficial, intraabdominal or intra-thoracic locations. 125 Implant Seeds may also be used in the treatment of residual tumors following completion of external beam radiation therapy and for other recurrent tumors.
    Device Description
    Not Found
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