GREY:TSTIF - Post by User
Post by
BlackAngus1979on Jun 26, 2019 10:17am
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Post# 29864479
FujiFilm Clearance (IFU)
FujiFilm Clearance (IFU)What are the chances that this gets done on time??? I will be shocked if this happens by July 1st.....Go
"Although the Fujifilm duodenoscope dimensions fall within TSO3's US Food and Drug Administration (FDA) cleared label claim for sterilization of long, flexible gastro-intestinal endoscopes (see claims at tso3.com), the additional data TSO3 will generate as a result of the testing is intended to further support customer needs for device documentation. There can be no assurance as to the results of this testing or that any additional regulatory submissions will be made other than claims already cleared for the sterilizer and the reprocessing of the endoscope. Results from this testing are anticipated by the end of the first half of 2019."