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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 K020892
Device Name ACIST GENTOO CONTRAST INJECTION SYSTEM
Applicant
Acist Medical Systems
7450 Flying Clouds Dr.
Suite 150
Eden Prairie,  MN  55344
Applicant Contact CARL M BEAURLINE
Correspondent
Acist Medical Systems
7450 Flying Clouds Dr.
Suite 150
Eden Prairie,  MN  55344
Correspondent Contact CARL M BEAURLINE
Regulation Number870.1650
Classification Product Code
DXT  
Date Received03/19/2002
Decision Date 01/27/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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