K-number	K231286
Device name	Chemfort® Catheter Adaptor
Applicant	Simplivia Healthcare , Ltd.
Product code	ONB
Device class	Class II
Decision date	Aug 2, 2023
Decision	Substantially Equivalent
Regulation	880.5440

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Source

View the full FDA submission: accessdata.fda.gov

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Chemfort® Catheter Adaptor

Everything you need for a 510(k) submission. Nothing you don't.