FDA 510(k) Application Details - K974006

Device Classification Name Needle, Hypodermic, Single Lumen

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510(K) Number K974006
Device Name Needle, Hypodermic, Single Lumen
Applicant BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
ONE BECTON DR.
FRANKLIN LAKES, NJ 07417-1880 US
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Contact GREG MORGON
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Regulation Number 880.5570

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Classification Product Code FMI
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Date Received 10/21/1997
Decision Date 01/22/1998
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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