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510(k) Data Aggregation

    K Number
    K001915
    Device Name
    GRAFT MARKER RING
    Manufacturer
    T. KOROS SURGICAL INSTRUMENTS CORP.
    Date Cleared
    2001-04-27

    (308 days)

    Product Code
    MAB
    Regulation Number
    870.3450
    Why did this record match?
    Applicant Name (Manufacturer) :

    T. KOROS SURGICAL INSTRUMENTS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002755
    Device Name
    NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE
    Manufacturer
    T. KOROS SURGICAL INSTRUMENTS CORP.
    Date Cleared
    2000-12-04

    (90 days)

    Product Code
    LRN
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    T. KOROS SURGICAL INSTRUMENTS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K954016
    Device Name
    VIDEOSCOPE W/IRRIGATION SHEATH
    Manufacturer
    T. KOROS SURGICAL INSTRUMENTS CORP.
    Date Cleared
    1996-01-25

    (153 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    T. KOROS SURGICAL INSTRUMENTS CORP.

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

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