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510(k) Data Aggregation
K Number
K980739Manufacturer
Date Cleared
1998-05-26
(90 days)
Product Code
Regulation Number
878.4350Type
TraditionalReference & Predicate Devices
N/A
Predicate For
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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