FDA 510(k) Application Details - K050470

Device Classification Name Device, Vascular, For Promoting Embolization

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510(K) Number K050470
Device Name Device, Vascular, For Promoting Embolization
Applicant CONCENTRIC MEDICAL, INC.
1380 SHOREBIRD WAY
MOUNTAIN VIEW, CA 94043 US
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Contact JEAN M CAILLOUETTE
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Regulation Number 870.3300

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Classification Product Code KRD
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Date Received 02/23/2005
Decision Date 05/06/2005
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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