K-number	K190163
Device name	ALARA Neuro Access Kit
Applicant	SurGenTec, LLC
Product code	PDQ
Device class	Class II
Decision date	Jul 16, 2019
Decision	Substantially Equivalent
Regulation	874.1820

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Source

View the full FDA submission: accessdata.fda.gov

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ALARA Neuro Access Kit

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