FDA 510(k) Application Details - K160593

Device Classification Name Device, Percutaneous Retrieval

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510(K) Number K160593
Device Name Device, Percutaneous Retrieval
Applicant COOK INCORPORATED
750 DANIELS WAY
BLOOMINGTON, IN 47404 US
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Contact Chad Schulenburg
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Regulation Number 870.5150

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Classification Product Code MMX
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Date Received 03/01/2016
Decision Date 09/02/2016
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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