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510(k) Data Aggregation

    K Number
    K980739
    Device Name
    HISTOFREEZER/ 17% SALICYLIC ACID-VERRUCA PLANTARIS
    Manufacturer
    ORASURE TECHNOLOGIES, INC.
    Date Cleared
    1998-05-26

    (90 days)

    Product Code
    GEH
    Regulation Number
    878.4350
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HISTOFREEZER/ 17% SALICYLIC ACID-VERRUCA PLANTARIS

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

    Histofreezer is indicated for use in the treatment of the following: Genital Warts Molluscum Contagiosum Seborrhoeic Keratosis Skin Tags Verruca Plantaris Verruca Vulgaris Verruca Plana

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "Histofreezer®/17% Salicylic Acid-Verruca Plantaris," which is a treatment for various skin conditions. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. The letter primarily focuses on the FDA's determination of substantial equivalence for the device. Therefore, I cannot extract the requested information from the provided text.

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