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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 K162988
Device Name PreludeSYNC Radial Compression Device
Applicant
Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan,  UT  84095
Applicant Contact Ileana Davis
Correspondent
Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan,  UT  84095
Correspondent Contact Ileana Davis
Regulation Number870.4450
Classification Product Code
DXC  
Date Received10/27/2016
Decision Date 01/25/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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