FDA 510(k) Application Details - K161170

Device Classification Name Needle, Hypodermic, Single Lumen

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510(K) Number K161170
Device Name Needle, Hypodermic, Single Lumen
Applicant Becton, Dickinson and Company
1 Becton Drive
Franklin Lakes, NJ 07417 US
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Contact Priyanka Apte
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Regulation Number 880.5570

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Classification Product Code FMI
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Date Received 04/26/2016
Decision Date 05/27/2016
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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