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510(k) Data Aggregation

    K Number
    K000199
    Device Name
    CORTEK MINI LAPAROSCOPE
    Manufacturer
    CORTEK ENDOSCOPY, INC.
    Date Cleared
    2000-04-13

    (83 days)

    Product Code
    HET
    Regulation Number
    884.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    CORTEK ENDOSCOPY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K000198
    Device Name
    CORTEK ARTHROSCOPE
    Manufacturer
    CORTEK ENDOSCOPY, INC.
    Date Cleared
    2000-04-11

    (81 days)

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

    CORTEK ENDOSCOPY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K000202
    Device Name
    CORTEK LAPAROSCOPES
    Manufacturer
    CORTEK ENDOSCOPY, INC.
    Date Cleared
    2000-03-31

    (70 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    CORTEK ENDOSCOPY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K000197
    Device Name
    CORTEK CYSTOSCOPE
    Manufacturer
    CORTEK ENDOSCOPY, INC.
    Date Cleared
    2000-03-03

    (42 days)

    Product Code
    FAJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    CORTEK ENDOSCOPY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K000200
    Device Name
    CORTEK URETHEROSCOPE
    Manufacturer
    CORTEK ENDOSCOPY, INC.
    Date Cleared
    2000-03-03

    (42 days)

    Product Code
    FGB
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    CORTEK ENDOSCOPY, INC.

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

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