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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 K083514
Device Name TERUMO SYRINGE WITH/WITHOUT NEEDLE
Applicant
Terumo Europe N.V.
Interleuvenlaan 40
Researchpark Zone 2
Leuven,  BE 3001
Applicant Contact M.J. AERTS
Correspondent
Terumo Europe N.V.
Interleuvenlaan 40
Researchpark Zone 2
Leuven,  BE 3001
Correspondent Contact M.J. AERTS
Regulation Number880.5860
Classification Product Code
FMF  
Date Received11/26/2008
Decision Date 05/22/2009
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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