K-number	K163055
Device name	Reprocessed Kendall SCD Express Foot Cuff
Applicant	Covidien
Product code	JOW
Device class	Class II
Decision date	Dec 23, 2016
Decision	Substantially Equivalent
Regulation	870.5800

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Source

View the full FDA submission: accessdata.fda.gov

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Reprocessed Kendall SCD Express Foot Cuff

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