FDA 510(k) Application Details - K141311

Device Classification Name Saline, Vascular Access Flush

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510(K) Number K141311
Device Name Saline, Vascular Access Flush
Applicant Becton, Dickinson and Company
1 Becton Drive
Franklin Lakes, NJ 07417 US
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Contact JUMA HOSHINO
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Regulation Number 880.5200

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Classification Product Code NGT
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Date Received 05/20/2014
Decision Date 07/25/2014
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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