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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Contact PASQUALE AMATO
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Regulation Number 880.5570

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Classification Product Code FMI
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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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