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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 K142636
Device Name Merit 10mL Syringe
Applicant
Merit Medical Systems, Inc.
1600 W Merit Parkway
South Jordan,  UT  84095
Applicant Contact Mridi Kumathe
Correspondent
Merit Medical Systems, Inc.
1600 W Merit Parkway
South Jordan,  UT  84095
Correspondent Contact Mridi Kumathe
Regulation Number880.5860
Classification Product Code
FMF  
Date Received09/17/2014
Decision Date 10/17/2014
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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