K-number	K192422
Device name	Steerable Introducer 12F
Applicant	Freudenberg Medical, LLC
Product code	DRA
Device class	Class II
Decision date	Oct 4, 2019
Decision	Substantially Equivalent
Regulation	870.1280

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Source

View the full FDA submission: accessdata.fda.gov

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Steerable Introducer 12F

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