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    K Number
    K972918
    Device Name
    RAPID FIRE HAIR IMPLANTER CAROUSEL
    Manufacturer
    APEX MEDICAL PRODUCTS, LLC.
    Date Cleared
    1997-10-27

    (81 days)

    Product Code
    GAH, PAN
    Regulation Number
    878.4800
    Why did this record match?
    Applicant Name (Manufacturer) :

    APEX MEDICAL PRODUCTS, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RAPID FIRE HAIR IMPLANTER CAROUSEL™ is in ended to be used for hair transplantation on the scalp. The RAPID FIRE HAIR IMPLANTER CAROUSEL™ is indicated where patients require one or more hair grafting sessions during which multiple grafts have to be implanted.
    Device Description
    The RAPID FIRE HAIR IMPLANTER CAROUSEL™ (Carousel) is a disposable mechanical device designed to facilitate a hair transplant. It consists of a circular Carousel designed to house hair grafts, a sharp end designed to create an opening in the skin of the scalp and a button end that activates the moving parts within the Carousel. The CAROUSEL consists of a stainless steel blade and the body composed of Lustran 348 resin.
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