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510(k) Data Aggregation

    K Number
    K001236
    Device Name
    RIZA BAND STRETCHER (RBS)-60000
    Manufacturer
    R-MED, INC.
    Date Cleared
    2000-07-17

    (90 days)

    Product Code
    FHN
    Regulation Number
    876.4400
    Type
    Traditional
    Panel
    Gastroenterology-Urology (GU)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    R-MED, 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

    K Number
    K953360
    Device Name
    R-MED ABDOMINAL WALL ELEVATOR
    Manufacturer
    R-MED, INC.
    Date Cleared
    1996-01-11

    (178 days)

    Product Code
    HET
    Regulation Number
    884.1720
    Type
    Traditional
    Panel
    Obstetrics and Gynecology (OB)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    R-MED, 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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