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510(k) Data Aggregation

    K Number
    K082110
    Device Name
    DUAL SYRINGE HOLDER
    Manufacturer
    SURGIN SURGICAL INSTRUMENTATION, INC.
    Date Cleared
    2009-06-17

    (324 days)

    Product Code
    FMG
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    SURGIN SURGICAL INSTRUMENTATION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K033236
    Device Name
    PRIZM KERATOME BLADE, MODEL MK8512M2
    Manufacturer
    SURGIN SURGICAL INSTRUMENTATION, INC.
    Date Cleared
    2004-03-26

    (172 days)

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

    SURGIN SURGICAL INSTRUMENTATION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Prizm Keratome Blade VII is to be used as a replacement blade for the blade in the non-disposable Moria M2 keratome for lamellar resection of the corner.
    Device Description
    Not Found
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    K Number
    K033182
    Device Name
    PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD
    Manufacturer
    SURGIN SURGICAL INSTRUMENTATION, INC.
    Date Cleared
    2004-01-30

    (121 days)

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

    SURGIN SURGICAL INSTRUMENTATION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SURGIN'S PRIZM BLADES ARE DESIGNATED AS REPLACEMENT BLADES FOR THE "BECTON DICKINSON BD - 3000 MICRO SURGICAL SYSTEM", TO BE USED FOR LAMELLAR RESECTION OF THE CORNEA
    Device Description
    Not Found
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    K Number
    K011195
    Device Name
    PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB
    Manufacturer
    SURGIN SURGICAL INSTRUMENTATION, INC.
    Date Cleared
    2001-11-06

    (201 days)

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

    SURGIN SURGICAL INSTRUMENTATION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K994015
    Device Name
    ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508
    Manufacturer
    SURGIN SURGICAL INSTRUMENTATION, INC.
    Date Cleared
    2000-03-15

    (110 days)

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

    SURGIN SURGICAL INSTRUMENTATION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Surgin Inc. AccuBlade(ACS Model MK8507 and Hansatome Model MK8508) are designed as replacement blades for the Chiron Vision Corp. Model ACS Keratomo and Chiron Hansatome microkeratome for lamellar resection of the cornea
    Device Description
    Not Found
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    K Number
    K980849
    Device Name
    SURGIN KIT
    Manufacturer
    SURGIN SURGICAL INSTRUMENTATION, INC.
    Date Cleared
    1998-07-09

    (154 days)

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

    SURGIN SURGICAL INSTRUMENTATION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is indicated for use with the Alcon Series 20,000 Legacy Phacoemulsifier. It may be utilized in phaco procedures in which either combined or segregated automated irrigation and aspiration is deemed appropriate.
    Device Description
    Not Found
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