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TS03 Inc Trust Units TSTIF

Healthcare Medical Instruments & Supplies


GREY:TSTIF - Post by User

TS03 Inc Trust Units > Duodenoscope Question
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Comment by echo2on May 25, 2019 12:28am
150 Views
Post# 29772797

RE:RE:RE:RE:Duodenoscope Question

RE:RE:RE:RE:Duodenoscope Questionhttps://www.tso3.com/sterizone#resources

  • 510(k) Premarket notification (K172191) for the STERIZONE VP4 Sterilizer — claims for multi-channel flexible endoscopes, that fall within certain dimensions, are supported by terminal sterilization safety and efficacy data submitted to FDA on certain scopes, such as a duodenoscope.  For a summary of the data that was submitted to the FDA on the sterilization of the Olympus® TJF-Q180V video duodenoscope, see Am. J. Infect. Control.


https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K172191

 
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