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510(k) Data Aggregation

    K Number
    K102683
    Device Name
    THE ADDITION
    Date Cleared
    2011-01-06

    (111 days)

    Product Code
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    OB THE-ADDITION, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The-Addition provides padding for patient comfort and aids in the retention of coupling media in a defined position.
    Device Description
    The-Addition is a pad that is temporarily applied to the ultrasound transducer and the toco transducer to facilitate patient comfort and aid in the retention of ultrasonic coupling gel. The-Addition is provided non-sterile for single use and is disposable.
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