LogoFDA 510(k) Search
Search Filters

Search Results

Found 5 results

510(k) Data Aggregation

    K Number
    K003036
    Device Name
    TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025
    Manufacturer
    RETINALABS.COM
    Date Cleared
    2000-12-22

    (84 days)

    Product Code
    KYG
    Regulation Number
    886.4360
    Why did this record match?
    Applicant Name (Manufacturer) :

    RETINALABS.COM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K000418
    Device Name
    PDT DOSECALCULATOR, MODEL 80000
    Manufacturer
    RETINALABS.COM
    Date Cleared
    2000-10-24

    (259 days)

    Product Code
    NDC
    Regulation Number
    868.1890
    Why did this record match?
    Applicant Name (Manufacturer) :

    RETINALABS.COM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K000457
    Device Name
    VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES
    Manufacturer
    RETINALABS.COM
    Date Cleared
    2000-05-09

    (88 days)

    Product Code
    HMX
    Regulation Number
    886.4350
    Why did this record match?
    Applicant Name (Manufacturer) :

    RETINALABS.COM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K000416
    Device Name
    TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001
    Manufacturer
    RETINALABS.COM
    Date Cleared
    2000-05-08

    (90 days)

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

    RETINALABS.COM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K000420
    Device Name
    SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003
    Manufacturer
    RETINALABS.COM
    Date Cleared
    2000-05-08

    (90 days)

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

    RETINALABS.COM

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

    Page 1 of 1