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FDA 510(k) Application Details - K090111
Device Classification Name
Needle, Hypodermic, Single Lumen
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510(K) Number
K090111
Device Name
Needle, Hypodermic, Single Lumen
Applicant
NOVO NORDISK INC.
100 COLLEGE ROAD WEST
PRINCETON, NJ 08540-7810 US
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Contact
RICK SPRING
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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
01/16/2009
Decision Date
02/01/2010
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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