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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
Original Applicant
BIOSPHERE MEDICAL, INC.
1050 hingham st.
rockland,  MA  02370
Original 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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