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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 K250971
Device Name Embosphere Microspheres
Applicant
Biosphere Medical, S.A.
Parc Des Nations Paris Nord 2
383 Rue De La Belle Etolle
Roissy-En-France,  FR 95700
Applicant Contact Rosene Amosse
Correspondent
Biosphere Medical, S.A.
Parc Des Nations Paris Nord 2
383 Rue De La Belle Etolle
Roissy-En-France,  FR 95700
Correspondent Contact Regina Gatse
Regulation Number870.3300
Classification Product Code
KRD  
Subsequent Product Codes
HCG   NAJ   NOY  
Date Received03/31/2025
Decision Date 05/16/2025
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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