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510(k) K983314

PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM by Nycomed Amersham Imaging — Product Code IZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1999
Date Received
September 21, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector, Contrast Medium, Automatic
Device Class
Class II
Regulation Number
870.1650
Review Panel
HO
Submission Type

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