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FDA 510(k) Application Details - K010026
Device Classification Name
Device, Neurovascular Embolization
More FDA Info for this Device
510(K) Number
K010026
Device Name
Device, Neurovascular Embolization
Applicant
BIOSPHERE MEDICAL, INC.
1050 HINGHAM ST.
ROCKLAND, MA 02370 US
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Contact
JOHN D BONASERA
Other 510(k) Applications for this Contact
Regulation Number
882.5950
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Classification Product Code
HCG
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More FDA Info for this Product Code
Date Received
01/03/2001
Decision Date
06/21/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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