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510(k) Data Aggregation

    K Number
    K060561
    Device Name
    CLEARADEX GEL
    Manufacturer
    CAMBRIDGEMED
    Date Cleared
    2006-05-30

    (88 days)

    Product Code
    KHJ
    Regulation Number
    874.3620
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAMBRIDGEMED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    CLEARADEX GEL is a space-occupying gel is intended for use by a medical professional: - to control minimal bleeding following ENT surgery - to separate and prevent adhesions between mucosal surfaces in the nasal cavity - as an adjunct to aid in the natural healing process during the postoperative period
    Device Description
    CLEARADEX GEL is a space-occupying gel
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