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510(k) Data Aggregation

    K Number
    K974253
    Device Name
    CPD COMMANDER
    Manufacturer
    SCIERAN TECHNOLOGIES, INC.
    Date Cleared
    1998-02-25

    (104 days)

    Product Code
    MRH
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCIERAN TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fluid/Gas Exchange and Viscous Fluid Delivery/Injection during ophthalmic surgery.
    Device Description
    Not Found
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    K Number
    K980085
    Device Name
    PHACO COMMANDER
    Manufacturer
    SCIERAN TECHNOLOGIES, INC.
    Date Cleared
    1998-02-24

    (46 days)

    Product Code
    HQC
    Regulation Number
    886.4670
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCIERAN TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Emulsification and aspiration of cataract
    Device Description
    Not Found
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    K Number
    K973749
    Device Name
    FRAG COMMANDER
    Manufacturer
    SCIERAN TECHNOLOGIES, INC.
    Date Cleared
    1997-12-08

    (68 days)

    Product Code
    HQC
    Regulation Number
    886.4670
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCIERAN TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in fragmentation and aspiration of the human lens
    Device Description
    Frag Commander™ Phacofragmentation Device
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    K Number
    K961738
    Device Name
    VIT COMMANDER SYSTEM
    Manufacturer
    SCIERAN TECHNOLOGIES, INC.
    Date Cleared
    1996-11-25

    (206 days)

    Product Code
    HQE
    Regulation Number
    886.4150
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCIERAN TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K960767
    Device Name
    LIGHT COMMANDER
    Manufacturer
    SCIERAN TECHNOLOGIES, INC.
    Date Cleared
    1996-08-26

    (182 days)

    Product Code
    FCT
    Regulation Number
    886.4335
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCIERAN TECHNOLOGIES, INC.

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

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