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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K050474
Device Name VEINNOVATIONS INFILTRATION SYSTEM
Applicant
VEINNOVATIONS, LLC
49 PLAIN STREET
NORTH ATTLEBORO,  MA  02760
Applicant Contact ROSINA ROBINSON
Correspondent
VEINNOVATIONS, LLC
49 PLAIN STREET
NORTH ATTLEBORO,  MA  02760
Correspondent Contact ROSINA ROBINSON
Regulation Number880.5725
Classification Product Code
FRN  
Subsequent Product Code
KGZ  
Date Received02/24/2005
Decision Date 04/14/2005
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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