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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 K083523
Device Name MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGE
Applicant
MERIT MEDICAL SYSTEMS, INC.
1600 WEST MERIT PKWY.
SOUTH JORDAN,  UT  84095
Applicant Contact SUSAN D SCOTT
Correspondent
MERIT MEDICAL SYSTEMS, INC.
1600 WEST MERIT PKWY.
SOUTH JORDAN,  UT  84095
Correspondent Contact SUSAN D SCOTT
Regulation Number870.1650
Classification Product Code
DXT  
Subsequent Product Code
MAV  
Date Received11/26/2008
Decision Date 02/04/2009
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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