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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 K984231
Device Name ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B
Applicant
Invasatec
7450 Flying Cloud Dr.
Suite 150
Eden Prairie,  MN  55344
Applicant Contact KATE ANDERSON
Correspondent
Invasatec
7450 Flying Cloud Dr.
Suite 150
Eden Prairie,  MN  55344
Correspondent Contact KATE ANDERSON
Regulation Number870.1650
Classification Product Code
DXT  
Date Received11/25/1998
Decision Date 05/31/2000
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
Recalls CDRH Recalls
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