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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, neurovascular embolization
510(k) Number K010026
Device Name EMBOGOLD MICROSPHERE
Applicant
BIOSPHERE MEDICAL, INC.
1050 HINGHAM ST.
ROCKLAND,  MA  02370
Applicant Contact JOHN D BONASERA
Correspondent
BIOSPHERE MEDICAL, INC.
1050 HINGHAM ST.
ROCKLAND,  MA  02370
Correspondent Contact JOHN D BONASERA
Regulation Number882.5950
Classification Product Code
HCG  
Date Received01/03/2001
Decision Date 06/21/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Special
Reviewed by Third Party No
Combination Product No
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