K-number	K190464
Device name	Penumbra System 3D Revascularization Device
Applicant	Penumbra, Inc.
Product code	NRY
Device class	Class II
Decision date	Apr 26, 2019
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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Penumbra System 3D Revascularization Device

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