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FDA 510(k) Application Details - K183578
Device Classification Name
Device, Vascular, For Promoting Embolization
More FDA Info for this Device
510(K) Number
K183578
Device Name
Device, Vascular, For Promoting Embolization
Applicant
Biosphere Medical, S.A.
Parc des Nations û Paris Nord 2, 383 rue de la Belle Etoile
Roissy en France 95700 FR
Other 510(k) Applications for this Company
Contact
Alix Fonlladosa
Other 510(k) Applications for this Contact
Regulation Number
870.3300
More FDA Info for this Regulation Number
Classification Product Code
KRD
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More FDA Info for this Product Code
Date Received
12/21/2018
Decision Date
06/18/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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