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510(k) Data Aggregation

    K Number
    K070596
    Device Name
    TOPICAL APPLICATOR
    Manufacturer
    SHARN, INC.
    Date Cleared
    2007-06-21

    (111 days)

    Product Code
    CCT
    Regulation Number
    868.5170
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHARN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for atomizing topical anesthetics to the oropharynx and upper airway regions
    Device Description
    The Topical applicator incorporates a small tube with atomizing tip which can connect to a syringe and when placed in the patient's mouth or throat and / or inside an endotracheal tube or in the nasal passages it then delivers topical anesthetic solutions.
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