K-number	K162271
Device name	Pro-Lock CT Safety Infusion Set
Applicant	Medcomp (Medical Components, Inc.)
Product code	PTI
Device class	Class II
Decision date	Apr 26, 2017
Decision	Substantially Equivalent
Regulation	880.5570

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Source

View the full FDA submission: accessdata.fda.gov

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Pro-Lock CT Safety Infusion Set

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