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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 K113822
Device Name QUADRASPHERE 30 TO 60
Applicant
BIOSPHERE MEDICAL, INC.
1050 HINGHAM ST.
ROCKLAND,  MA  02370
Applicant Contact LINDA J VARROSO
Correspondent
BIOSPHERE MEDICAL, INC.
1050 HINGHAM ST.
ROCKLAND,  MA  02370
Correspondent Contact LINDA J VARROSO
Regulation Number882.5950
Classification Product Code
HCG  
Date Received12/27/2011
Decision Date 03/08/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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