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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K001572
Device Name NEOLUS NEEDLE
Applicant
TERUMO EUROPE N.V.
RESEARCHPARK ZONE 2
INTERLEUVENLAAN 40
LEUVEN 3001,  BE 3001
Applicant Contact M J AERTS
Correspondent
TERUMO EUROPE N.V.
RESEARCHPARK ZONE 2
INTERLEUVENLAAN 40
LEUVEN 3001,  BE 3001
Correspondent Contact M J AERTS
Regulation Number880.5570
Classification Product Code
FMI  
Date Received05/22/2000
Decision Date 08/14/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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