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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name saline, vascular access flush
510(k) Number K121050
Device Name 0.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRINGE, SF FLUSH SYRINGE
Original Applicant
BECTON DICKINSON & CO.
1 becton drive
franklin lakes,  NJ  07417
Original Contact john roberts
Regulation Number880.5200
Classification Product Code
NGT  
Date Received04/06/2012
Decision Date 02/07/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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