K-number	K142918
Device name	EndoTool SubQ
Applicant	Monarch Medical Technologies
Product code	NDC
Device class	Class II
Decision date	Apr 24, 2015
Decision	Substantially Equivalent
Regulation	868.1890

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Source

View the full FDA submission: accessdata.fda.gov

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EndoTool SubQ

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