K-number	K200083
Device name	EMBA Hourglass Peripheral Embolization Device (PED)
Applicant	Embolic Acceleration, LLC
Product code	KRD
Device class	Class II
Decision date	Feb 14, 2020
Decision	Substantially Equivalent
Regulation	870.3300

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Source

View the full FDA submission: accessdata.fda.gov

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EMBA Hourglass Peripheral Embolization Device (PED)

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