K-number	K161940
Device name	Guidewire 0.6 Single Use
Applicant	Fiagon GmbH
Product code	PGW
Device class	Class II
Decision date	Sep 18, 2016
Decision	Substantially Equivalent
Regulation	882.4560

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Source

View the full FDA submission: accessdata.fda.gov

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Guidewire 0.6 Single Use

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