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510(k) Data Aggregation

    K Number
    K041110
    Device Name
    MB 105 MILLENNIUM BLADES
    Manufacturer
    MILLENNIUM BIOMEDICAL, INC.
    Date Cleared
    2004-10-13

    (168 days)

    Product Code
    HNO
    Regulation Number
    886.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    MILLENNIUM BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MB 105 Millennium blade is intended to be used as a replacement blade for the Moria M2 Non-Disposable Microkeratome.
    Device Description
    The MB 105 Millennium Blade is a replacement blade designed to be used with the Moria M2 Non Disposable Microkeratome. The MB 105 Millennium Blade is a single-use only, disposable device. The Blade material is similar to that used in predicate devices (stainless steel).
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    K Number
    K011833
    Device Name
    MB 103 MILLENNIUM BLADES
    Manufacturer
    MILLENNIUM BIOMEDICAL, INC.
    Date Cleared
    2002-02-15

    (248 days)

    Product Code
    HNO
    Regulation Number
    886.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    MILLENNIUM BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MB 103 Millennium blade is intended to be used as a replacement blade for the Moria CB Microkeratome.
    Device Description
    The MB 103 Millennium Blade is a replacement blade designed to be used with the Moria CB Microkeratome. The MB 103 Millennium Blade is a single-use only, disposable device. The Blade material is similar to that used in predicate devices (stainless steel).
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    K Number
    K020122
    Device Name
    MB 102 MILLENNIUM BLADES
    Manufacturer
    MILLENNIUM BIOMEDICAL, INC.
    Date Cleared
    2002-02-15

    (32 days)

    Product Code
    HNO
    Regulation Number
    886.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    MILLENNIUM BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MB 102 Millennium blade is intended to be used as a replacement blade for the Hansatome™ Microkeratome.
    Device Description
    The MB 102 Millennium Blade is a replacement blade designed to be used with the Hansatome™ Microkeratome. The MB 102 Millennium Blade is a single-use only, disposable device. The blade material is similar to that used in predicate devices (stainless steel).
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    K Number
    K003143
    Device Name
    MILLENNIUM BLADES, MODEL MB101
    Manufacturer
    MILLENNIUM BIOMEDICAL, INC.
    Date Cleared
    2000-12-11

    (62 days)

    Product Code
    HNO
    Regulation Number
    886.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    MILLENNIUM BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001806
    Device Name
    REFRACTIVE SURGERY BLADES
    Manufacturer
    MILLENNIUM BIOMEDICAL, INC.
    Date Cleared
    2000-09-12

    (89 days)

    Product Code
    HNO
    Regulation Number
    886.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    MILLENNIUM BIOMEDICAL, INC.

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

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