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FDA 510(k) Applications for Medical Device Product Code "NOY"
FDA 510(k) Number
Applicant
Device Name
Decision Date
K203276
Biocompatibles UK Ltd (part of Boston Scientific Corporation
Bead Block (100 - 300╡m, 1ml), Bead Block (300 - 500╡m, 1ml), Bead Block (500 - 700╡m, 1ml), Bead Block (700 - 900╡m, 1ml), Bead Block (900 - 1200╡m, 1ml), Bead Block (100 - 300╡m, 2ml), Bead Block (300 - 500╡m, 2ml), Bead Block (500 - 700╡m, 2ml), Bead B
04/20/2021
DEN160040
Biosphere Medical S.A.
Embosphere Microspheres
06/21/2017
K180102
Boston Scientific
Embozene Color-Advanced Microspheres
04/19/2018
K192684
MicroVention, Inc.
HydroPearl Microspheres
01/22/2020
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