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FDA 510(k) Application Details - K052834
Device Classification Name
Device, Vascular, For Promoting Embolization
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510(K) Number
K052834
Device Name
Device, Vascular, For Promoting Embolization
Applicant
COOK, INC.
750 DANIELS WAY
P.O. BOX 489
BLOOMINGTON, IN 47402 US
Other 510(k) Applications for this Company
Contact
LISA M WEBB
Other 510(k) Applications for this Contact
Regulation Number
870.3300
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Classification Product Code
KRD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/06/2005
Decision Date
11/23/2005
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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