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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector And Syringe, Angiographic
510(k) Number K160107
Device Name DiamondTOUCH Inflation Device and Fluid Dispensing Syringe
Applicant
Merit Medical Systems, Inc.
1600w Merit Pkwy.
South Jordan,  UT  84095
Applicant Contact Dan W Lindsay
Correspondent
Merit Medical Systems, Inc.
1600w Merit Pkwy.
South Jordan,  UT  84095
Correspondent Contact Dan W Lindsay
Regulation Number870.1650
Classification Product Code
DXT  
Subsequent Product Code
MAV  
Date Received01/19/2016
Decision Date 07/29/2016
Decision Substantially Equivalent - Kit (SESK)
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
Recalls CDRH Recalls
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