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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Vascular, For Promoting Embolization
510(k) Number K183120
Device Name EmboCube Embolization Gelatin
Applicant
Biosphere Medical, S.A.
Parc Des Nations – Paris Nord 2, 383, Rue De La Belle Etoile
Roissy-En-France,  FR 95700
Applicant Contact Alix Fonlladosa
Correspondent
Biosphere Medical, S.A.
Parc Des Nations – Paris Nord 2, 383, Rue De La Belle Etoile
Roissy-En-France,  FR 95700
Correspondent Contact Rosene Amosse
Regulation Number870.3300
Classification Product Code
KRD  
Date Received11/09/2018
Decision Date 08/06/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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