K-number	K203144
Device name	MicroPen EVO
Applicant	Eclipse Medcorp, LLC
Product code	QAI
Device class	Class II
Decision date	May 25, 2021
Decision	Substantially Equivalent
Regulation	878.4430

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Source

View the full FDA submission: accessdata.fda.gov

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MicroPen EVO

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