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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
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