K-number	K190233
Device name	K-Shield Advantage Port Access Infusion Set (PAIS)
Applicant	Kawasumi Laboratories, Inc.
Product code	FPA
Device class	Class II
Decision date	May 2, 2019
Decision	Substantially Equivalent
Regulation	880.5440

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View the full FDA submission: accessdata.fda.gov

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K-Shield Advantage Port Access Infusion Set (PAIS)

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