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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 K113198
Device Name NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML
Applicant
NAVILYST MEDICAL, INC.
26 FOREST STREET
MARLBOROUGH,  MA  01752
Applicant Contact MARION W GORDON
Correspondent
NAVILYST MEDICAL, INC.
26 FOREST STREET
MARLBOROUGH,  MA  01752
Correspondent Contact MARION W GORDON
Regulation Number870.1650
Classification Product Code
DXT  
Date Received10/31/2011
Decision Date 11/28/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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