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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 K111091
Device Name MERIT MEDICAL 20 ML SYRINGE
Original Applicant
MERIT MEDICAL SYSTEMS, INC.
1600 west merit pkwy.
south jordan,  UT  84095
Original Contact michaela rivkowich
Regulation Number880.5860
Classification Product Code
FMF  
Date Received04/19/2011
Decision Date 06/24/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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