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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 K131710
Device Name MERIT HYDROPHILIC GUIDE WIRE
Applicant
Merit Medical Systems, Inc.
Parkmore Business Park W.
Galway,  IE EI
Applicant Contact MARTHA FOLAN
Correspondent
Merit Medical Systems, Inc.
Parkmore Business Park W.
Galway,  IE EI
Correspondent Contact MARTHA FOLAN
Regulation Number870.1330
Classification Product Code
DQX  
Date Received06/11/2013
Decision Date 07/29/2013
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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