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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 K983826
Device Name 3S INJECTOR-CT CONTRAST DELIVERY SYSTEM
Applicant
Unimachs Corp.
7475 Wisconsin Ave.,
Suite 850
Bethesda,  MD  20814
Applicant Contact EDUARDO MARCH
Correspondent
Unimachs Corp.
7475 Wisconsin Ave.,
Suite 850
Bethesda,  MD  20814
Correspondent Contact EDUARDO MARCH
Regulation Number870.1650
Classification Product Code
DXT  
Date Received10/29/1998
Decision Date 03/23/2000
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
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