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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K033721
Device Name VASCULAR SOLUTIONS AUTO-FILL SYRINGE KIT
Applicant
Vascular Solutions, Inc.
6464 Sycamore Ct.
Minneapolis,  MN  55369
Applicant Contact SARA L COON
Correspondent
Vascular Solutions, Inc.
6464 Sycamore Ct.
Minneapolis,  MN  55369
Correspondent Contact SARA L COON
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
FPA  
Date Received11/26/2003
Decision Date 02/13/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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