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FDA 510(k) Application Details - K112185
Device Classification Name
Device, Percutaneous Retrieval
More FDA Info for this Device
510(K) Number
K112185
Device Name
Device, Percutaneous Retrieval
Applicant
COOK, INC.
750 DANIELS WAY
BLOOMINGTON, IN 47404 US
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Contact
MOLLY BUSENBARK
Other 510(k) Applications for this Contact
Regulation Number
870.5150
More FDA Info for this Regulation Number
Classification Product Code
MMX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/29/2011
Decision Date
11/02/2011
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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