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TS03 Inc Trust Units TSTIF

Healthcare Medical Instruments & Supplies


GREY:TSTIF - Post by User

TS03 Inc Trust Units > FDA clears first duodenoscope with disposable distal cap
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Comment by Marginofsafteyon Sep 21, 2017 2:05pm
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Post# 26726896

RE:FDA clears first duodenoscope with disposable distal cap

RE:FDA clears first duodenoscope with disposable distal cap

As echo2 mentioned,

"On the Pentax site, there is no IFU for sterilization, only instructions for HLD (that ha been repeated found to be inadequate), suggesting that Pentax had submitted the 510k for this new scope before the August regulation changes requiring sterilization data and instructions for use with new pre-market approval applications."

Read more at https://www.stockhouse.com/companies/bullboard/t.tos/tso3-inc?postid=26723335#CbrTvLcId8sH8Dux.99"

MarginofSaftey

 

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