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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name clamp, vascular
510(k) Number K180723
Device Name PreludeSYNC DISTAL Radial Compression System
Applicant
Merit Medical Systems, Inc
1600 West Merit Parkway
South Jordan,  UT  84095
Applicant Contact Susan Christensen
Correspondent
Merit Medical Systems, Inc
1600 West Merit Parkway
South Jordan,  UT  84095
Correspondent Contact Susan Christensen
Regulation Number870.4450
Classification Product Code
DXC  
Date Received03/19/2018
Decision Date 04/17/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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