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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K173601
Device Name Merit Syringe
Applicant
Merit Medical Systems, Inc.
1600 W Merit Parkway
South Jordan,  UT  84045
Applicant Contact Cory Marsh
Correspondent
Merit Medical Systems, Inc.
1600 W Merit Parkway
South Jordan,  UT  84045
Correspondent Contact Cory Marsh
Regulation Number880.5860
Classification Product Code
FMF  
Date Received11/21/2017
Decision Date 01/31/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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