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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Intravascular, Cardiovascular
510(k) Number K162875
Device Name Sentry IVC filter
Applicant
Novate Medical , Ltd.
Block 11, Galway Technology Park
Parkmore
Galway,  IE
Applicant Contact GORDON CROWLEY
Correspondent
Novate Medical , Ltd.
Block 11, Galway Technology Park
Parkmore
Galway,  IE
Correspondent Contact GORDON CROWLEY
Regulation Number870.3375
Classification Product Code
DTK  
Date Received10/14/2016
Decision Date 02/17/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT01975090
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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