FDA 510(k) Application Details - K152560

Device Classification Name Device, Percutaneous Retrieval

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510(K) Number K152560
Device Name Device, Percutaneous Retrieval
Applicant NEOMETRICS, INC
2605 FERNBROOK LANE, SUITE J
PLYMOUTH, MN 55447 US
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Contact DAVE LIEBL
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Regulation Number 870.5150

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Classification Product Code MMX
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Date Received 09/09/2015
Decision Date 10/23/2015
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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