K-number	K200041
Device name	FlexPointer 1.5 Single Use, FlexTube 3 Single Use
Applicant	Fiagon GmbH
Product code	PGW
Device class	Class II
Decision date	Mar 10, 2020
Decision	Substantially Equivalent
Regulation	882.4560

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Source

View the full FDA submission: accessdata.fda.gov

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FlexPointer 1.5 Single Use, FlexTube 3 Single Use

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