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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 K181202
Device Name Sentry IVC Filter
Applicant
Novate Medical , Ltd.
Block 11, Galway Technology Park, Parkmore,
Galway,  IE H91 VE0H
Applicant Contact Gordon Crowley
Correspondent
Novate Medical , Ltd.
Block 11, Galway Technology Park, Parkmore,
Galway,  IE H91 VE0H
Correspondent Contact Gordon Crowley
Regulation Number870.3375
Classification Product Code
DTK  
Date Received05/07/2018
Decision Date 06/06/2018
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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