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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 K123609
Device Name MERIT HYDROPHILIC GUIDE WIRE
Applicant
MERIT MEDICAL SYSTEMS, INC.
1111 South Velasco St
Angleton,  TX  77515
Applicant Contact STEPHANIE ERSKINE
Correspondent
MERIT MEDICAL SYSTEMS, INC.
1111 South Velasco St
Angleton,  TX  77515
Correspondent Contact STEPHANIE ERSKINE
Regulation Number870.1330
Classification Product Code
DQX  
Date Received11/21/2012
Decision Date 01/16/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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