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510(k) Data Aggregation

    K Number
    K970306
    Device Name
    MARKMAN TEMPLATE SYSTEM
    Manufacturer
    BARRY MARKMAN, M.D.
    Date Cleared
    1997-11-20

    (297 days)

    Product Code
    GAH
    Regulation Number
    878.4800
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    BARRY MARKMAN, M.D.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Template System will be used solely for hair restoration. The device will first create slits in a recipient site in the scalp, and then insert hair grafts into these slits. Cartridges preloaded with hair grafts will facilitate insertion in an efficient manner.

    Device Description

    The Template System will be used solely for hair restoration. The device will first create slits in a recipient site in the scalp, and then insert hair grafts into these slits. Cartridges preloaded with hair grafts will facilitate insertion in an efficient manner.

    AI/ML Overview

    I apologize, but the provided text from the FDA 510(k) letter for the Markman Template System does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

    This document is solely an FDA clearance letter indicating that the device has been deemed "substantially equivalent" to a predicate device and can be marketed. It outlines regulatory requirements but does not delve into the technical details of device validation.

    Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the other specific questions you posed based on the given input.

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