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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
Applicant
Becton, Dickinson & CO
1 Becton Dr.
Franklin Lakes,  NJ  07417
Applicant Contact JOHN ROBERTS
Correspondent
Becton, Dickinson & CO
1 Becton Dr.
Franklin Lakes,  NJ  07417
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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