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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 K062265
Device Name CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM
Applicant
Swiss Medical Care S.A.
32 Stratton Ct.
Flemington,  NJ  08822
Applicant Contact ROBERT AROMANDO
Correspondent
Swiss Medical Care S.A.
32 Stratton Ct.
Flemington,  NJ  08822
Correspondent Contact ROBERT AROMANDO
Regulation Number870.1650
Classification Product Code
IZQ  
Date Received08/04/2006
Decision Date 12/26/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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