K-number	K232609
Device name	Micro Ace Advanced Micro Access System
Applicant	Merit Medical Systems, Inc.
Product code	DRE
Device class	Class II
Decision date	Sep 27, 2023
Decision	Substantially Equivalent
Regulation	870.1310

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Source

View the full FDA submission: accessdata.fda.gov

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Micro Ace Advanced Micro Access System

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Micro Ace Advanced Micro Access System