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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K160643
Device Name ENROUTE 0.014 Guidewire
Applicant
Lake Region Medical
Parkmore W Business Park
Galway,  IE G07001
Applicant Contact MICHAEL DUNNING
Correspondent
Lake Region Medical
Parkmore W Business Park
Galway,  IE G07001
Correspondent Contact MICHAEL DUNNING
Regulation Number870.1330
Classification Product Code
DQX  
Date Received03/07/2016
Decision Date 10/18/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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