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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 K913994
Device Name MONARCH(TM) INFLATION SYRINGE
Applicant
Merit Medical Systems, Inc.
79 W. 4500 S., Suite 9
Salt Lake City,  UT  84107
Applicant Contact DENNIS REIGLE
Correspondent
Merit Medical Systems, Inc.
79 W. 4500 S., Suite 9
Salt Lake City,  UT  84107
Correspondent Contact DENNIS REIGLE
Regulation Number870.1650
Classification Product Code
MAV  
Date Received09/06/1991
Decision Date 02/04/1992
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
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