Pma/510k: reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u.S.K111959.If additional information becomes available, a follow up report will be submitted.
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It was reported that there was ampoule leakage.The reporter indicated that when opening the package, the leakage from two ampules were already caused, therefore the product was not able to be used.Also, there was one ample that was empty.Additional information was not available.
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