LogoFDA 510(k) Search
Search Filters

Search Results

Found 10 results

510(k) Data Aggregation

    K Number
    K955685

    Validate with FDA (Live)

    Device Name
    RNS STERILE, DISPOSABLE CT BIOPSY TRAY
    Manufacturer
    CONTOUR FABRICATORS OF FLORIDA, INC.
    Date Cleared
    1996-10-04

    (295 days)

    Product Code
    DXT
    Regulation Number
    870.1650
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K962040

    Validate with FDA (Live)

    Device Name
    RNS ARTHROGRAM TRAY
    Manufacturer
    CONTOUR FABRICATORS OF FLORIDA, INC.
    Date Cleared
    1996-06-25

    (32 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Type
    Traditional
    Panel
    General Hospital
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K955687

    Validate with FDA (Live)

    Device Name
    RNS STERILE, DISPOSABLE RADIOGRAPHIC CONTRAST TRAY
    Manufacturer
    CONTOUR FABRICATORS OF FLORIDA, INC.
    Date Cleared
    1996-06-03

    (172 days)

    Product Code
    JAA
    Regulation Number
    892.1650
    Type
    Traditional
    Panel
    Radiology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K955689

    Validate with FDA (Live)

    Device Name
    RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY
    Manufacturer
    CONTOUR FABRICATORS OF FLORIDA, INC.
    Date Cleared
    1996-05-15

    (153 days)

    Product Code
    DWS
    Regulation Number
    870.4500
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K955684

    Validate with FDA (Live)

    Device Name
    RNS STERILE, DISPOSABLE ANGIOGRAPHIC TRAY
    Manufacturer
    CONTOUR FABRICATORS OF FLORIDA, INC.
    Date Cleared
    1996-05-02

    (140 days)

    Product Code
    DXT
    Regulation Number
    870.1650
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K955679

    Validate with FDA (Live)

    Device Name
    RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY
    Manufacturer
    CONTOUR FABRICATORS OF FLORIDA, INC.
    Date Cleared
    1996-03-12

    (89 days)

    Product Code
    HIO
    Regulation Number
    884.1550
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K955678

    Validate with FDA (Live)

    Device Name
    RNS STERILE DISPOSABLE PUNCTURE TRAY
    Manufacturer
    CONTOUR FABRICATORS OF FLORIDA, INC.
    Date Cleared
    1996-02-21

    (69 days)

    Product Code
    FRG
    Regulation Number
    880.6850
    Type
    Traditional
    Panel
    General Hospital
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K955688

    Validate with FDA (Live)

    Device Name
    RNS STERILE, DISPOSABLE STANDARD BIOPSY TRAY
    Manufacturer
    CONTOUR FABRICATORS OF FLORIDA, INC.
    Date Cleared
    1996-02-21

    (69 days)

    Product Code
    FRG
    Regulation Number
    880.6850
    Type
    Traditional
    Panel
    General Hospital
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K955686

    Validate with FDA (Live)

    Device Name
    RNS, STERILE DISPOSABLE PERCUTANEOUS CHOLANGIOGRAPHIC TRAY
    Manufacturer
    CONTOUR FABRICATORS OF FLORIDA, INC.
    Date Cleared
    1996-02-21

    (69 days)

    Product Code
    FRG
    Regulation Number
    880.6850
    Type
    Traditional
    Panel
    General Hospital
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K955683

    Validate with FDA (Live)

    Device Name
    RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAY
    Manufacturer
    CONTOUR FABRICATORS OF FLORIDA, INC.
    Date Cleared
    1996-02-01

    (49 days)

    Product Code
    MJG
    Regulation Number
    878.4800
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1