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FDA 510(k) Application Details - K131358
Device Classification Name
Needle, Hypodermic, Single Lumen
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510(K) Number
K131358
Device Name
Needle, Hypodermic, Single Lumen
Applicant
BECTON DICKINSON & CO.
1 BECTON DRIVE
MC 372
FRANKLIN LAKES, NJ 07417-1885 US
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PASQUALE AMATO
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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
05/10/2013
Decision Date
07/16/2013
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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