K-number	K210482
Device name	Medline UNITE REFLEX Nitinol Staple System
Applicant	Medline Industries, Inc.
Product code	JDR
Device class	Class II
Decision date	Apr 22, 2021
Decision	Substantially Equivalent
Regulation	888.3030

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Source

View the full FDA submission: accessdata.fda.gov

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Medline UNITE REFLEX Nitinol Staple System

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