K-number	K171193
Device name	Certa Catheter
Applicant	Ferrosan Medical Devices Sp. Z.O.O.
Product code	BSO
Device class	Class II
Decision date	Dec 18, 2017
Decision	Substantially Equivalent
Regulation	868.5120

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Source

View the full FDA submission: accessdata.fda.gov

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Certa Catheter

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