FDA 510(k) Application Details - K151870

Device Classification Name Syringe, Piston

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510(K) Number K151870
Device Name Syringe, Piston
Applicant BECTON, DICKINSON AND COMPANY
1 BECTON DRIVE
FRANKLIN LAKES, NJ 07666 US
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Contact LUISA F. METRIO
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Regulation Number 880.5860

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Classification Product Code FMF
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Date Received 07/09/2015
Decision Date 07/08/2016
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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