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510(k) Data Aggregation

    K Number
    K955732
    Device Name
    VENTED SOLUTION SET
    Manufacturer
    DISTRONIC STERILE PRODUCTS, INC.
    Date Cleared
    1996-02-21

    (64 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    DISTRONIC STERILE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K955709
    Device Name
    WINGED & SUBCUTANEOUS INFUSION SETS
    Manufacturer
    DISTRONIC STERILE PRODUCTS, INC.
    Date Cleared
    1996-02-21

    (65 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    DISTRONIC STERILE PRODUCTS, INC.

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

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    K Number
    K954983
    Device Name
    EXTENSION SET WITH CHECK VALVE
    Manufacturer
    DISTRONIC STERILE PRODUCTS, INC.
    Date Cleared
    1996-01-23

    (84 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    DISTRONIC STERILE PRODUCTS, INC.

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

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    K Number
    K954984
    Device Name
    MINIBORE STOPCOCK SET
    Manufacturer
    DISTRONIC STERILE PRODUCTS, INC.
    Date Cleared
    1996-01-23

    (84 days)

    Product Code
    FMG
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    DISTRONIC STERILE PRODUCTS, INC.

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

    Ask a specific question about this device

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