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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name syringe, balloon inflation
510(k) Number K040138
Device Name VICEROY INFLATION DEVICE
Applicant
MERIT MEDICAL SYSTEMS, INC.
1600 WEST MERIT PKWY.
SOUTH JORDAN,  UT  84095
Applicant Contact JOHN NICHOLSON
Correspondent
KEMA QUALITY B.V.
P.O. BOX 5185
6802 ED ARNHEM
ARNHEM,  NL
Correspondent Contact J.A. VAN VUGT
Regulation Number870.1650
Classification Product Code
MAV  
Date Received01/22/2004
Decision Date 02/13/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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