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FDA 510(k) Application Details - K110527
Device Classification Name
Needle, Hypodermic, Single Lumen
More FDA Info for this Device
510(K) Number
K110527
Device Name
Needle, Hypodermic, Single Lumen
Applicant
TERUMO EUROPE N.V.
INTERLEUVENLAAN 40
LEUVEN 3001 BE
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Contact
M. J AERTS
Other 510(k) Applications for this Contact
Regulation Number
880.5570
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Classification Product Code
FMI
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More FDA Info for this Product Code
Date Received
02/24/2011
Decision Date
06/06/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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