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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 K070547
Device Name SURFLO WINGED INFUSION SET WITH FILTER AND NEEDLE PROTECTION (SURSHIELD)
Applicant
TERUMO EUROPE N.V.
RESEARCHPARK ZONE 2
INTERLEUVENLAAN 40
leuven,  BE 3001
Applicant Contact m.j. aerts
Correspondent
TERUMO EUROPE N.V.
RESEARCHPARK ZONE 2
INTERLEUVENLAAN 40
leuven,  BE 3001
Correspondent Contact m.j. aerts
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/26/2007
Decision Date 05/25/2007
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
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