K-number	K220458
Device name	UltraFlo-R Push Button Blood Collection Set
Applicant	Innovative Medical Technologies, Inc.
Product code	JKA
Device class	Class II
Decision date	Sep 29, 2023
Decision	Substantially Equivalent
Regulation	862.1675

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Source

View the full FDA submission: accessdata.fda.gov

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UltraFlo-R Push Button Blood Collection Set

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