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FDA 510(k) Application Details - K043371
Device Classification Name
Device, Vascular, For Promoting Embolization
More FDA Info for this Device
510(K) Number
K043371
Device Name
Device, Vascular, For Promoting Embolization
Applicant
BIOMERIX CORPORATION
1700 ROCKVILLE PIKE
SUITE 400
ROCKVILE, MD 20852 US
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Contact
CHRISTINA L KICHULA
Other 510(k) Applications for this Contact
Regulation Number
870.3300
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Classification Product Code
KRD
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More FDA Info for this Product Code
Date Received
12/08/2004
Decision Date
02/03/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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