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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 K884913
Device Name MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM)
Applicant
MERIT MEDICAL SYSTEMS, INC.
79 WEST 4500 SOUTH
SUITE 9
SALT LAKE CITY,  UT  84107
Applicant Contact FRED LAMPROPOULOS
Correspondent
MERIT MEDICAL SYSTEMS, INC.
79 WEST 4500 SOUTH
SUITE 9
SALT LAKE CITY,  UT  84107
Correspondent Contact FRED LAMPROPOULOS
Regulation Number870.1650
Classification Product Code
DXT  
Date Received11/28/1988
Decision Date 04/18/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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