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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K100946
Device Name INTRAVSCULAR ADMINISTRATION SET
Applicant
Terumo Europe N.V.
Interleuvenlaan 40
Leuven,  BE 3001
Applicant Contact M.J. AERTS
Correspondent
Terumo Europe N.V.
Interleuvenlaan 40
Leuven,  BE 3001
Correspondent Contact M.J. AERTS
Regulation Number880.5440
Classification Product Code
FPA  
Date Received04/06/2010
Decision Date 08/02/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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