K-number	DEN160040
Device name	Embosphere Microspheres
Applicant	Biosphere Medical, S.A.
Product code	NOY
Device class	Class II
Decision date	Jun 21, 2017
Decision	Not Substantially Equivalent
Regulation	876.5550

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Source

View the full FDA submission: accessdata.fda.gov

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Embosphere Microspheres

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