K-number	K192998
Device name	Reprocessed BRK Transseptal Needle
Applicant	Innovative Health, LLC
Product code	NMK
Device class	Class II
Decision date	Jul 22, 2020
Decision	Substantially Equivalent
Regulation	870.1390

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Source

View the full FDA submission: accessdata.fda.gov

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Reprocessed BRK Transseptal Needle

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