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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Blood Circuit, Hemodialysis
510(k) Number K030456
Device Name VASC-ALERT
Applicant
Vasc-Alert, LLC
1807 W. Sunnyside Ave.
Suite 301
Chicago,  IL  60640
Applicant Contact JOHN KENNEDY
Correspondent
Vasc-Alert, LLC
1807 W. Sunnyside Ave.
Suite 301
Chicago,  IL  60640
Correspondent Contact JOHN KENNEDY
Regulation Number876.5820
Classification Product Code
KOC  
Date Received02/11/2003
Decision Date 07/11/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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