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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector, Contrast Medium, Automatic
510(k) Number K983314
Device Name PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM
Applicant
NYCOMED AMERSHAM IMAGING
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Applicant Contact ROSINA ROBINSON
Correspondent
NYCOMED AMERSHAM IMAGING
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Correspondent Contact ROSINA ROBINSON
Regulation Number870.1650
Classification Product Code
IZQ  
Date Received09/21/1998
Decision Date 02/19/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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