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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Percutaneous Retrieval
510(k) Number K151497
Device Name EN Snare Endovascular Snare System
Applicant
Merit Medical Systems, Inc.
Parkmore Business Park W.
Galway,  IE
Applicant Contact MARK MULLANEY
Correspondent
Merit Medical Systems, Inc.
Parkmore Business Park W.
Galway,  IE
Correspondent Contact SIOBHAN KING
Regulation Number870.5150
Classification Product Code
MMX  
Date Received06/04/2015
Decision Date 07/01/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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