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510(k) Data Aggregation

    K Number
    K011929
    Device Name
    HANDPIECE SHEATH-MODEL #A910
    Manufacturer
    AARON MEDICAL, INC.
    Date Cleared
    2001-09-18

    (90 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    AARON MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Aaron 910 handpiece Sheath is intended to be used as an accessory to electrosurgical handpieces. The sheath is placed over the handpiece and provides a barrier to minimize contamination. The Handpiece Sheath is non-sterile and is intended for single patient use only.
    Device Description
    The Aaron A910 Handpiece Sheath is a non-sterile, disposable electrosurgical handpiece cover that is designed to fit over an electrosurgical handpiece to provide a barrier between the handpiece and the patient, thus prevent contamination of the handpiece.
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